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

Balgrist University Hospital

Status: Completed

Conditions: Back Pain; Back Pain, Low; Back Pain With Radiation

Treatments: Procedure: Control spinal manual therapy protocol; Procedure: Active spinal manual therapy protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05778396

SALuBRITY Blinding

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 2 patient groups

Active spinal manual therapy protocol

Active Comparator group

Description:

(1) Side-lying lumbar spine manipulation, (2) prone lumbar spine mobilization, and (3) prone thoracic spine manipulation.

Treatment:

Procedure: Active spinal manual therapy protocol

Control spinal manual therapy protocol

Sham Comparator group

Description:

(1) Control side-lying lumbar spine manipulation, (2) control prone lumbar spine mobilization, and (3) control prone thoracic spine manipulation.

Treatment:

Procedure: Control spinal manual therapy protocol