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

NCT05778396 | Completed

• 1 other identifier: SALuBRITY Blinding
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain; Back Pain With Radiation; Back Pain, Low

Keywords

Methods; Manual therapy; Randomized trial; Back pain; Blinding assessment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Participant blinding success, as measured by the validated James blinding index, immediately after intervention session 1.

  Immediately after intervention session 1 (study day 1)

• Participant blinding success, as measured by the validated James blinding index, immediately after intervention session 2.

  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.

  Immediately after intervention session 1 (study day 1)

• Outcome assessor blinding success, as measured by the validated Bang index, immediately after intervention session 2.

  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.

  Immediately after intervention session 1 (study day 1)

Other Outcomes (31)

• Lumbar spine range of motion, immediately before intervention session 1.

  Immediately before intervention session 1 (study day 1)

• Lumbar spine range of motion, immediately after intervention session 1.

  Immediately after intervention session 1 (study day 1)

• Lumbar spine range of motion, immediately before intervention session 2.

  Immediately before intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)

Study Arms (2)

Active spinal manual therapy protocol

ACTIVE COMPARATOR

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

Procedure: Active spinal manual therapy protocol

Control spinal manual therapy protocol

SHAM COMPARATOR

(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

Interventions

Active spinal manual therapy protocol PROCEDURE

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.

Active spinal manual therapy protocol

Control spinal manual therapy protocol PROCEDURE

(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.

Control spinal manual therapy protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• With or without experience of spinal manual therapy
• With or without experience of current low back pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Balgrist University Hospital: lead
• University of Zurich: collaborator

Study Sites (1)

Balgrist University Hospital and CHIROMED Praxis im Seefeld

Zurich, 8008, Switzerland

Location

Related Publications (2)

• Munoz Laguna J, Kurmann A, Hofstetter L, Nyantakyi E, Braun J, Clack L, Bang H, Farshad M, Foster NE, Puhan MA, Hincapie CA; SALuBRITY Blinding Clinician Group. 'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapy. Chiropr Man Therap. 2025 Jan 14;33(1):4. doi: 10.1186/s12998-024-00561-0.

  PMID: 39810207 DERIVED

• Munoz Laguna J, Kurmann A, Hofstetter L, Nyantakyi E, Clack L, Bang H, Foster NE, Braun J, Puhan MA, Farshad M, Hincapie CA. Feasibility of blinding spinal manual therapy interventions among participants and outcome assessors: protocol for a blinding feasibility trial. Pilot Feasibility Stud. 2024 May 2;10(1):70. doi: 10.1186/s40814-024-01492-6.

  PMID: 38698433 DERIVED

MeSH Terms

Conditions

Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cesar A Hincapié, DC PhD

  Balgrist University Hospital and University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, managing clinicians, outcome assessors, data analysts, and investigators will be blinded to intervention assigned. Only treating clinicians will not be blinded to the interventions but will be trained and asked not to disclose the intervention, nature of the interventions, nor trial objectives to trial participants or other members of the trial team.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist and Head of Musculoskeletal Epidemiology Research

Model Details: Two-parallel-group, single-centre, sham-controlled, methodological blinding feasibility randomised trial.

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 21, 2023
• Study Start: April 4, 2023
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

CH (1)