Feasibility of Spinal Manual Therapy Interventions for a Future Clinical

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05778396
Study type	Interventional
Source	Balgrist University Hospital
Contact
Status	Completed
Phase	N/A
Start date	April 4, 2023
Completion date	April 25, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms