Feasibility of Spinal Manual Therapy Interventions for a Future Clinical Study of Back Pain

Study Overview
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Brief Summary
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This study aims to compare two different spinal manual therapy interventions of the back to determine if they are viable and acceptable for a future study investigating the treatment of patients with back pain. The two proposed spinal manual therapy interventions are widely used in the fields of chiropractic, physical therapy, osteopathy, and manual medicine to treat back pain and improve function. This is a randomized study, meaning that participants are randomly assigned (like tossing a coin) to one of two manual spinal therapy interventions.

Detailed Description
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Clinical trials of spinal manual therapy interventions for back pain and back-related leg pain face methodological challenges regarding the design of effective sham control ('control' hereafter) and blinding of the assigned interventions. Although the assessment of blinding is often neglected in the field of manual medicine, the implementation of high-quality trials of spinal manual therapy interventions warrants formal evaluation of blinding feasibility among participants and outcome assessors to advance randomized clinical trial methods and design. The objectives of this blinding feasibility trial are: To assess the feasibility of blinding participants, with or without experience of spinal manual therapy or current low back pain, randomly allocated to an active or control spinal manual therapy intervention protocol. To assess the feasibility of blinding managing clinicians (non-treating clinicians or outcome assessors) within the randomised trial context. To examine the impact of spinal manual therapy experience in the past 3 months (Yes vs No) and presence of low back pain during the past four weeks (average intensity ≤2 versus ≥3 out of 10) on the feasibility of participant and managing clinician blinding. To explore factors contributing to participant and managing clinician perceptions about the assigned intervention (active versus control) using a qualitative thematic analysis.

Official Title
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Feasibility of Blinding Spinal Manual Therapy Interventions for a Trial Assessing Management of Primary Care Patients With Back Pain: the SALuBRITY Blinding Feasibility Randomised Controlled Trial

Conditions
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Back Pain, Back Pain With Radiation, Back Pain, Low

Intervention / Treatment
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* Procedure: Active spinal manual therapy protocol
* Procedure: Control spinal manual therapy protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older With or without experience of spinal manual therapy With or without experience of current low back pain Exclusion Criteria: Serious spinal pathology (e.g. spinal fracture, cancer or infection) History of lumbar spine surgery Currently under care or in consultation with a specialist, chiropractor, physiotherapist, or osteopath for current back pain Manual medicine health care provider (i.e., chiropractor, physiotherapist, osteopath, massage therapist, manual medicine trained physician) Have a serious comorbidity preventing them from attending the research clinic and receiving the interventions Pregnant or breastfeeding status Involved in pending litigation related to back pain Already participating in another research study related to back pain

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-parallel-group, single-centre, sham-controlled, methodological blinding feasibility randomised trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active spinal manual therapy protocol<br>(1) Side-lying lumbar spine manipulation, (2) prone lumbar spine mobilization, and (3) prone thoracic spine manipulation. | Procedure: Active spinal manual therapy protocol<br>* The chiropractor will start by (1) placing one hand over L4-L5 or L5-S1 and then will apply a high-velocity, low-amplitude (HVLA) thrust with a therapeutic line of drive. Side-lying lumbar manipulation will be performed bilaterally, with the treating clinician choosing any suitable technique and with or without occurrence of the characteristic audible joint cavitation associated with spine manipulation. The chiropractor will then perform (2) prone lumbar mobilisation by placing the contact hand and applying downward pressure over L4-L5 or L5-S1 with the other hand guiding a manual flexion-distraction piece to apply therapeutic mobilization of the lumbar spine. The chiropractor will deliver (3) a prone thoracic manipulation by placing two hands over the transverse processes of T5-T6 or T6-T7 and applying a HVLA thrust in a posterior-to-anterior direction.<br>|
| Sham Comparator: Control spinal manual therapy protocol<br>(1) Control side-lying lumbar spine manipulation, (2) control prone lumbar spine mobilization, and (3) control prone thoracic spine manipulation. | Procedure: Control spinal manual therapy protocol<br>* (1) Control side-lying lumbar manipulation will be operationalised as the application of a low-velocity broad push manoeuvre to the gluteal region following a non-therapeutic line of drive. The chiropractor will then perform (2) control prone lumbar mobilisation, consisting of a non-therapeutic manual manoeuvre involving minimal oscillations (0 to ±2°) of the flexion-distraction piece with light touch over the lumbar spine region, and (3) control prone thoracic mobilisation consisting of two-handed left and right scapula pushes with a nontherapeutic line of drive.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant blinding success, as measured by the validated Bang blinding index, immediately after intervention session 1. | The blinding assessment survey item will ask: Which treatment do you believe you received? with five response options provided: Strongly believe I received the genuine treatment, Somewhat believe I received the genuine treatment, Somewhat believe I received the control treatment, Strongly believe I received the control treatment, and I do not know which treatment I received. Bang BI estimates (between -1 to +1, with 0 indicating satisfactory blinding) can be interpreted as the proportion of correct guesses beyond chance within an intervention arm. For the Bang BI, a score with an absolute value of ≤0.3 (i.e., -0.3 to 0.3) will be deemed compatible with satisfactory blinding, and blinding scenarios will be discussed. | Immediately after intervention session 1 (study day 1) | 
| Participant blinding success, as measured by the validated Bang blinding index, immediately after intervention session 2. | The blinding assessment survey item will ask: Which treatment do you believe you received? with five response options provided: Strongly believe I received the genuine treatment, Somewhat believe I received the genuine treatment, Somewhat believe I received the control treatment, Strongly believe I received the control treatment, and I do not know which treatment I received. Bang BI estimates (between -1 to +1, with 0 indicating satisfactory blinding) can be interpreted as the proportion of correct guesses beyond chance within an intervention arm. For the Bang BI, a score with an absolute value of ≤0.3 (i.e., -0.3 to 0.3) will be deemed compatible with satisfactory blinding, and blinding scenarios will be discussed. | Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant blinding success, as measured by the validated James blinding index, immediately after intervention session 1. | The James BI, a modification of the kappa statistic that measures disagreement beyond chance, returns a value between 0 and 1, with 1 equal to all don't know responses (complete blinding), 0 equal to all correct responses (complete unblinding), and 0.5 where respondents' responses appear random (50% correct, 50% incorrect). | Immediately after intervention session 1 (study day 1) | 
| Participant blinding success, as measured by the validated James blinding index, immediately after intervention session 2. | The James BI, a modification of the kappa statistic that measures disagreement beyond chance, returns a value between 0 and 1, with 1 equal to all don't know responses (complete blinding), 0 equal to all correct responses (complete unblinding), and 0.5 where respondents' responses appear random (50% correct, 50% incorrect). | Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1) | 
| Outcome assessor blinding success, as measured by the validated Bang index, immediately after intervention session 1. | Bang BI estimates (between -1 to +1, with 0 indicating satisfactory blinding) can be interpreted as the proportion of correct guesses beyond chance within an intervention arm. | Immediately after intervention session 1 (study day 1) | 
| Outcome assessor blinding success, as measured by the validated Bang index, immediately after intervention session 2. | Bang BI estimates (between -1 to +1, with 0 indicating satisfactory blinding) can be interpreted as the proportion of correct guesses beyond chance within an intervention arm. | Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1) | 
| Outcome assessor blinding success, as measured by the validated James index, immediately after intervention session 1. | The James BI measures disagreement beyond chance and returns a value between 0 and 1, with 1 equal to all don't know responses (complete blinding), 0 equal to all correct responses (complete unblinding), and 0.5 where respondents' responses appear random (50% correct, 50% incorrect). | Immediately after intervention session 1 (study day 1) | 
| Outcome assessor blinding success, as measured by the validated James index, immediately after intervention session 2. | The James BI measures disagreement beyond chance and returns a value between 0 and 1, with 1 equal to all don't know responses (complete blinding), 0 equal to all correct responses (complete unblinding), and 0.5 where respondents' responses appear random (50% correct, 50% incorrect). | Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methods, Manual therapy, Randomized trial, Back pain, Blinding assessment