NCT05778396

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Balgrist University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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: 1. 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. 2. To assess the feasibility of blinding managing clinicians (non-treating clinicians or outcome assessors) within the randomised trial context. 3. 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. 4. To explore factors contributing to participant and managing clinician perceptions about the assigned intervention (active versus control) using a qualitative thematic analysis.

Conditions

• Back Pain
• Back Pain With Radiation
• Back Pain, Low

Interventions

Type	Name	Description
PROCEDURE	Active spinal manual therapy protocol	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.
PROCEDURE	Control spinal manual therapy protocol	(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.

Timeline

• Start date: 2023-04-04
• Primary completion: 2023-04-25
• Completion: 2023-04-25
• First posted: 2023-03-21
• Last updated: 2023-06-02

Locations

1 site across 1 country: Switzerland