The effects of osteopathic manipulative treatment on pain and disability in patients with chronic neck pain: A single-blinded randomized controlled trial

Abstract

Background: Neck pain (NP) affects up to 70% of individuals at some point in their lives. Systematic reviews indicate that manual treatments can be moderately effective in the management of chronic, nonspecific NP. However, there is a paucity of studies specifically evaluating the efficacy of osteopathic manipulative treatment (OMT).

Objective: To evaluate the efficacy of OMT in reducing pain and disability in patients with chronic NP.

Design: Single-blinded, cross-over, randomized-controlled trial.

Setting: University-based, osteopathic manipulative medicine outpatient clinic.

Participants: Ninety-seven participants, 21 to 65 years of age, with chronic, nonspecific NP.

Interventions: Participants were randomized to two trial arms: immediate OMT intervention or waiting period first. The intervention consisted of three to four OMT sessions over 4 to 6 weeks, after which the participants switched groups.

Main outcome measures: Primary outcome measures were pain intensity (average and current) on the numerical rating scale and Neck Disability Index. Secondary outcomes included Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) health domains and Fear Avoidance Beliefs Questionnaire. Outcomes obtained prior to the cross-over allocation were evaluated using general linear models and after adjusting for baseline values.

Results: A total of 38 and 37 participants were available for the analysis in the OMT and waiting period groups, respectively. The results showed significantly better primary outcomes in the immediate OMT group for reductions in average pain (-1.02, 95% confidence interval [CI] -1.72, -0.32; p = .005), current pain (-1.02, 95% CI -1.75, -0.30; p = .006), disability (-5.30%, 95% CI -9.2%, -1.3%; p = .010) and improved secondary outcomes (PROMIS) related to sleep (-3.25, 95% CI -6.95, -1.54; p = .003), fatigue (-3.26, 95% CI -6.04, -0.48; p = .022), and depression (-2.59, 95% CI -4.73, -0.45; p = .018). The effect sizes were in the clinically meaningful range between 0.5 and 1 standard deviation. No study-related serious adverse events were reported.

Conclusions: OMT is relatively safe and effective in reducing pain and disability along with improving sleep, fatigue, and depression in patients with chronic NP immediately following treatment delivered over approximately 4 to 6 weeks.

Figure 1.

Schematic of the randomized, cross-over, controlled trial design. Subjects in the AB arm received treatment (A – OMT intervention) followed by no treatment (B - waiting period); whereas subjects in the BA arm received no treatment (B - waiting period) followed by treatment (A – OMT intervention). Patient-reported outcomes were collected at baseline (T₀), cross-over point (T₁), and end of the trial (T₂). These three time points were spaced approximately 4–6 weeks.

Figure 2.

CONSORT flow diagram of participants. Because of the carryover effects in the primary outcomes, the comparison between study groups was carried out prior to the cross-over allocation at T₁ (indicated with a red dashed line) with 38 participants in the immediate OMT intervention group and 37 participants in the waiting period group.

Figure 3.

Carryover effects in the primary outcome measures by trial arm. Both unadjusted and adjusted analyses revealed the significant group differences (P<0.05) at T₁ time point for average pain (a), current pain (b), and Neck Disability Index (NDI) (c). The allocation sequences indicate OMT intervention as A and waiting period as B. Error bars indicate standard errors. T₀ - baseline, T₁ - cross-over time point, T₂ - study completion.