Clinical trial NCT05778396: Feasibility of Spinal Manual Therapy Interventions for a Future Clinical Study of Back Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Back Pain With Radiation
Back Pain, Low
Keywords: Methods
Manual therapy
Randomized trial
Back pain
Blinding assessment
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2023-03-21
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-parallel-group, single-centre, sham-controlled, methodological blinding feasibility randomised trial.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Participant blinding success, as measured by the validated Bang blinding index, immediately after intervention session 1.
timeFrame: Immediately after intervention session 1 (study day 1)
measure: Participant blinding success, as measured by the validated Bang blinding index, immediately after intervention session 2.
timeFrame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
Secondary outcomes:
measure: Participant blinding success, as measured by the validated James blinding index, immediately after intervention session 1.
timeFrame: Immediately after intervention session 1 (study day 1)
measure: Participant blinding success, as measured by the validated James blinding index, immediately after intervention session 2.
timeFrame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Outcome assessor blinding success, as measured by the validated Bang index, immediately after intervention session 1.
timeFrame: Immediately after intervention session 1 (study day 1)
measure: Outcome assessor blinding success, as measured by the validated Bang index, immediately after intervention session 2.
timeFrame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Outcome assessor blinding success, as measured by the validated James index, immediately after intervention session 1.
timeFrame: Immediately after intervention session 1 (study day 1)
measure: Outcome assessor blinding success, as measured by the validated James index, immediately after intervention session 2.
timeFrame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
Other outcomes:
measure: Lumbar spine range of motion, immediately before intervention session 1.
timeFrame: Immediately before intervention session 1 (study day 1)
measure: Lumbar spine range of motion, immediately after intervention session 1.
timeFrame: Immediately after intervention session 1 (study day 1)
measure: Lumbar spine range of motion, immediately before intervention session 2.
timeFrame: Immediately before intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Lumbar spine range of motion, immediately after intervention session 2.
timeFrame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Self-rated general health, immediately before intervention session 1.
timeFrame: Immediately before intervention session 1 (study day 1)
measure: Self-rated general health, immediately after intervention session 1.
timeFrame: Immediately after intervention session 1 (study day 1)
measure: Self-rated general health, immediately before intervention session 2.
timeFrame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Self-rated general health, immediately after intervention session 2.
timeFrame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Pain intensity, current, immediately before intervention session 1.
timeFrame: Immediately before intervention session 1 (study day 1)
measure: Pain intensity, current, immediately after intervention session 1.
timeFrame: Immediately after intervention session 1 (study day 1)
measure: Pain intensity, current, immediately before intervention session 2.
timeFrame: Immediately before intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Pain intensity, current, immediately after intervention session 2.
timeFrame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Pain intensity, past week, immediately before intervention session 1.
timeFrame: Immediately before intervention session 1 (study day 1)
measure: Pain intensity, past week, immediately before intervention session 2.
timeFrame: Immediately before intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Satisfaction with care, immediately after intervention session 1.
timeFrame: Immediately after intervention session 1 (study day 1)
measure: Satisfaction with care, immediately after intervention session 2.
timeFrame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Back function - self-reported flexibility, immediately before intervention session 1.
timeFrame: Immediately before intervention session 1 (study day 1)
measure: Back function - self-reported flexibility, immediately after intervention session 1.
timeFrame: Immediately after intervention session 1 (study day 1)
measure: Back function - self-reported flexibility, immediately before intervention session 2.
timeFrame: Immediately before intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Back function - self-reported flexibility, immediately after intervention session 2.
timeFrame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Back function - self-reported back function, immediately before intervention session 1.
timeFrame: Immediately before intervention session 1 (study day 1)
measure: Back function - self-reported back function, immediately after intervention session 1.
timeFrame: Immediately after intervention session 1 (study day 1)
measure: Back function - self-reported back function, immediately before intervention session 2.
timeFrame: Immediately before intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Back function - self-reported back function, immediately after intervention session 2.
timeFrame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Back function - self-reported ache, pain, discomfort in the mid and low back, immediately before intervention 1.
timeFrame: Immediately before intervention session 1 (study day 1)
measure: Back function - self-reported ache, pain, discomfort in the mid and low back, immediately before intervention 2.
timeFrame: Immediately before intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Participant's reasons for beliefs about intervention assigned, immediately after intervention session 1.
timeFrame: Immediately after intervention session 1 (study day 1)
measure: Participant's reasons for beliefs about intervention assigned, immediately after intervention session 2.
timeFrame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Outcome assessor's reasons for beliefs about intervention assigned, immediately after intervention session 1.
timeFrame: Immediately after intervention session 1 (study day 1)
measure: Outcome assessor's reasons for beliefs about intervention assigned, immediately after intervention session 2.
timeFrame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
measure: Participant credibility/expectancy of active and control interventions, as measured with the credibility/expectancy questionnaire, immediately after intervention session 2.
timeFrame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
Locations:
city: Zürich
country: Switzerland
facility: Balgrist University Hospital and CHIROMED Praxis im Seefeld
Study officials:
affiliation: Balgrist University Hospital and University of Zurich
name: Cesar A Hincapié, DC PhD
role: PRINCIPAL_INVESTIGATOR
References: