Measuring the Context of Healing in Chronic Pain Treatment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Measuring the Context of Healing in Chronic Pain Treatment (NCT02873429), a registered phase not stated study. The primary outcome is PROMIS Pain Intensity.

2. Clinical Question

3. Trial Design

This completed study, titled “Measuring the Context of Healing in Chronic Pain Treatment,” was sponsored by the University of Pittsburgh. The registry record lists a start date of 2015-02, primary completion in 2016-12, and enrollment of 218. Chronic pain is the listed condition.

The study examined whether nonspecific factors, alongside patient characteristics, contribute to differences in treatment outcomes. Its stated aims included evaluating whether the Healing Encounters and Attitudes Lists (HEAL) predict chronic pain treatment outcomes; examining heterogeneity of treatment effects based on HEAL and PROMIS scores in integrative and conventional medicine settings; and interviewing patients and clinicians about the utility of HEAL, PROMIS, and a Pain Log for communication.

The registry describes an integrative medicine group receiving chiropractic care, acupuncture, massage therapy, or meditation training, and a conventional medicine group receiving care such as physical therapy, medication management, or injections. The record explicitly cautions that this was not a randomized comparison, allocation was not stated, and the arms are not a like-for-like control comparison. The group descriptions therefore identify care settings; they do not establish that the groups were exchangeable or that differences between them can be attributed to a particular treatment.

HEAL instruments assess patient-provider connection, treatment expectancy, views of the healthcare environment, positive and negative attitudes, spirituality, and attitudes toward complementary and alternative medicine. The project also describes use of PROMIS computerized adaptive tests for depression, anxiety, sleep disturbance, fatigue, and physical function. The registry lists Clinical Global Impression of Change as a secondary outcome. It does not report further design details, the interview findings, or results for these measures.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: 9 participants enrolled (completed consent) and did not continue in the study: 2 Integrative / Complementary Alternative Medicine (CAM) and 1 Conventional withdrew after signing consent form; 2 CAM and 4 Conventional did not meet eligibility criteria after signing consent form.

Baseline

6-8 Weeks

Reasons for not completing this period:

16 Weeks

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as PROMIS Pain Intensity, measured over 6-8 weeks.

The primary endpoint is PROMIS Pain Intensity, measured at 6-8 weeks and reported as a mean with a standard deviation on a T-score metric. The measure uses three items about pain at its worst during the past week, average pain during the past week, and current pain. Each item uses a five-point response scale ranging from no pain to very severe pain.

The item scores are summed to form a raw score ranging from 3 to 15, then converted to a T-score. The registry states that 50 is the mean and 10 the standard deviation of the relevant reference population. These reference values describe the scoring metric; they are not results for this study's participants.

Pain intensity is used as a patient-reported measure of pain severity, the outcome relevant to the study's chronic pain focus. A mean describes the average score in a group, while a standard deviation describes how spread out individual scores are around that mean. Those summaries can characterize measured pain intensity, but interpretation of a group contrast also requires the actual estimates and details of the comparison. Neither the endpoint values nor an estimated contrast is reported in the registry record, so the direction, size, and precision of any observed change cannot be assessed from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods describe how collected measurements are turned into estimates and how uncertainty is assessed. The registry identifies PROMIS Pain Intensity as a continuous outcome summarized by a mean and standard deviation. It does not report the model or inferential procedure used for the study, so the discussion below explains general principles rather than asserting which methods the investigators applied.

What does a mean and standard deviation describe?

For a continuous measure, a mean is a summary of the values in a group. A standard deviation describes their spread around the mean. The registry specifies these summaries for PROMIS Pain Intensity, a T-score measure derived from the three pain-intensity items. The metric's reference mean of 50 and reference standard deviation of 10 are properties of the relevant reference population, not the study's observed mean or spread.

Group summaries alone do not answer whether groups differ. An analysis comparing groups would need to estimate a contrast and account for the variability and amount of outcome information. A confidence interval, when reported, describes a range of values compatible with the data and the analysis assumptions; it communicates precision as well as the estimated direction and size. A p-value, when reported, quantifies how unusual the data would be under a specified null model. Neither is a measure of clinical importance by itself. No confidence interval or p-value is reported in this registry record.

Why does the care-setting comparison need caution?

General statistical principle: random assignment can help balance measured and unmeasured participant characteristics across groups, on average. The record does not describe random assignment and specifically says this was not a randomized comparison, allocation was not stated, and the arms are not a like-for-like control comparison. A contrast between the groups would therefore be an observational comparison unless further design information established otherwise. Such a contrast can be affected by differences in who receives each type of care, as well as by the care itself.

Adjustment for measured characteristics can sometimes reduce confounding, but it cannot guarantee that all relevant differences have been addressed. The registry record does not report covariate adjustment, matching, weighting, or another approach to confounding. It also does not report participant-level baseline characteristics or an analysis plan. No causal conclusion about one care setting versus the other can be drawn from the group descriptions alone.

What is meant by prediction and heterogeneity?

Prediction concerns whether information measured for a patient, such as a HEAL or PROMIS score, is associated with a later outcome. A useful assessment needs more than a statement of the study aim: it generally requires a specified outcome and predictor, an estimated relationship, and information about how well predictions perform. The record does not report these estimates or validation procedures.

Heterogeneity of treatment effects means that the effect of treatment may vary across subgroups or along a measured characteristic. Testing this requires an analysis of differences in effects, not merely separate descriptions of outcomes within groups. In a nonrandomized comparison, the interpretation is especially sensitive to confounding and to how treatment and participant characteristics are modeled. The registry describes the aim but does not report the analysis or its findings.

Why can over-dispersion matter?

General statistical principle: an analysis can be too confident if its model assumes less variability than the data contain. Over-dispersion refers to observed variation greater than expected under a particular model. It can make standard errors too small and confidence intervals too narrow if not accommodated. This concept is most relevant to outcomes analyzed with models that specify a particular variance structure; the listed primary outcome is continuous and summarized by a mean and standard deviation. The registry does not identify a model or report over-dispersion checks, so it is not possible to say whether this issue arose or how it was handled.

What can planning calculations tell readers?

Sample-size calculations are planning illustrations, not observed evidence about the study's results. The registry's stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between the arms, a normal approximation, and effects expressed as fractions of the observed effect. For non-time-to-event outcomes, the calculations are expressed as participants per arm for 80% power or other stated power levels; the record says time-to-event calculations instead give a total number of events. These assumptions do not describe the study's own design justification, which is not reported in the registry record. Numerical planning results are also not reported in the information available for this analysis. Such calculations must not be interpreted as observed power or as evidence that an effect was present.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Integrative Medicine Group", "Conventional Medicine Group")
n   <- c(105, 98)
m   <- c(50.1, 52.9)
sp  <- c(6.6, 6.2)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Integrative Medicine Group  105  50.100  6.600  48.823  51.377
CARM  Conventional Medicine Group  98  52.900  6.200  51.657  54.143

11. Multiplicity, Missing Data and Analysis Populations

The study lists a primary outcome, PROMIS Pain Intensity, and names Clinical Global Impression of Change as a secondary outcome. It also describes several HEAL and PROMIS measures and multiple aims. The registry record does not report a statistical analysis plan, a hierarchy for testing outcomes, or how multiplicity across outcomes, predictors, subgroups, or analyses was handled. When many hypotheses are examined, the chance of at least one apparently notable result can increase; methods for controlling or interpreting that issue depend on the prespecified analysis strategy. No such strategy is reported.

The record does not describe missing-data rates for the primary or other outcomes, reasons for missingness, or methods used to address missing observations. It does not report whether analyses used complete cases, imputation, or another approach. Missingness can affect both the amount of information and the representativeness of analyzed participants, so these details matter for interpreting estimates.

Analysis populations are not described. The record does not say which participants were included in each analysis or how changes in care, incomplete assessments, or other departures were handled. It also does not report interim analyses, stopping rules, or a statistical plan. These omissions prevent assessment of whether analyses followed prespecified procedures and how much flexibility there may have been in selecting analyses. The registry lists no analyses, so these statistical details and results are not available in the record.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry reports serious adverse events and other adverse events separately for the integrative medicine and conventional medicine groups. For the integrative medicine group, the number at risk is 109 for each category, with 0 affected by serious adverse events, 0 affected by other adverse events, and 0 deaths. For the conventional medicine group, the number at risk is 100 for each category, with 0 affected by serious adverse events, 0 affected by other adverse events, and 0 deaths. No top serious-event terms are listed.

These entries describe the adverse-event counts recorded in the registry. They do not establish that no adverse events occurred outside the reporting definitions, observation period, or data captured in the record. The registry information does not describe event ascertainment, follow-up duration for safety, or how events were classified. The group denominators should not be treated as the number contributing to the primary endpoint, which is not reported. The safety figures also do not make the two nonrandomized care groups directly comparable for safety.

13. What the Result Does, and Does Not, Mean

The registry record establishes that the study was completed and describes an investigation of healing-related measures, patient characteristics, and chronic pain outcomes in integrative and conventional medicine settings. It identifies PROMIS Pain Intensity at 6-8 weeks as the primary outcome and describes other measures and aims. It does not report the primary outcome results, estimates for the prediction or heterogeneity questions, or findings from the patient and clinician interviews.

Accordingly, the record does not show whether pain intensity changed, whether group outcomes differed, or whether HEAL scores predicted outcomes. It also does not show the magnitude or precision of any association. These questions cannot be answered by the study aims, the enrollment figure, or the completion status alone.

Even if a group contrast were reported, the registry's caution that the comparison was not randomized and was not like-for-like would matter. An observed association between care setting and outcome would not, by itself, demonstrate that the care caused the difference. Differences in participant characteristics and other factors may contribute, and the record does not describe an adjustment strategy.

The reported zero counts for adverse events are registry entries, not proof that no harms occurred in every sense. The record does not give enough information to assess event ascertainment or the relationship between these figures and the primary outcome follow-up.

The results and analysis details not reported in the registry record should not be filled in by assumption. The statistically appropriate conclusion is limited: the record describes the questions and measures, but does not provide the outcome evidence needed to answer them.

14. Why This Trial Matters Statistically

This study is statistically relevant because it addresses more than an average comparison between care settings. Its stated aims include examining whether patient-reported context measures predict outcomes and whether treatment effects vary across HEAL and PROMIS scores. These questions distinguish prediction from treatment-effect heterogeneity, which require different analyses and interpretations.

The registry also makes an important design qualification explicit: the comparison was not randomized, allocation was not stated, and the arms are not a like-for-like control comparison. That caveat is central to interpreting any between-group association. Statistical adjustment may address some measured differences, but does not automatically remove confounding or turn an observational comparison into a randomized one.

The primary outcome illustrates the value and limits of standardized patient-reported measurement. PROMIS Pain Intensity converts three pain ratings to a T-score metric referenced to a relevant population. Standardization can make scores interpretable on a consistent scale, but a reference metric does not substitute for reporting study-specific group summaries, estimated contrasts, and uncertainty.

The registry's missing analysis results also highlight the difference between a study's research aims and evidence answering those aims. Without estimates, uncertainty intervals, analysis populations, and missing-data methods, readers cannot evaluate the strength or robustness of any relationship. The study is therefore informative as a description of a planned research approach, while the registry record does not provide the statistical findings needed to assess its substantive questions.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record contains no primary outcome values, group means, standard deviations, estimated effects, confidence intervals, or p-values. It lists no analyses. This prevents assessment of the direction, magnitude, precision, or statistical compatibility of any outcome contrast or predictor association.

Design information is limited. The record states that the comparison was not randomized, allocation was not stated, and the arms are not a like-for-like control comparison. It does not report baseline characteristics, how participants entered each care setting, or how potential confounding was addressed. The integrative and conventional groups also encompass different types of care, so the group labels do not describe a single uniform treatment in either arm.

The record does not report eligibility criteria in detail, participant characteristics, the number contributing to outcome analyses, follow-up completeness, missing-data methods, analysis populations, or statistical models. It does not report a statistical analysis plan or how multiplicity across outcomes and aims was handled. The primary endpoint is defined, but the record does not provide the study-specific scores needed to interpret it.

The registry lists safety counts but does not explain adverse-event collection, classification, or observation procedures. It also describes interview aims without reporting interview methods or findings. These limits apply to what can be concluded from the registry record; they do not establish what may have been reported elsewhere.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Measuring the Context of Healing in Chronic Pain Treatment — NCT02873429.
• Registry record last updated 2017-08-02; status last verified 2017-04.
• Results first posted 2017-08-02.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT02873429 is a completed University of Pittsburgh study of chronic pain titled “Measuring the Context of Healing in Chronic Pain Treatment.” The record lists enrollment of 218, a start date of 2015-02, and primary completion in 2016-12. It describes integrative and conventional medicine groups and aims involving HEAL, PROMIS, treatment outcomes, and patient-clinician communication.

The primary outcome is PROMIS Pain Intensity, summarized as a mean and standard deviation on a T-score metric at 6-8 weeks. Clinical Global Impression of Change is listed as a secondary outcome. The registry says the comparison was not randomized, allocation was not stated, and the arms are not a like-for-like control comparison.

Outcome estimates, statistical analyses, missing-data methods, and analysis populations are not reported in the registry record. The recorded adverse-event counts are zero for serious events, other events, and deaths in both groups.