Blinding Assessment of Manual Therapy Interventions of the Back in Swiss Graduate Students

NCT05822947 | Completed

• 1 other identifier: SENSATE Blinding
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

There is marked uncertainty regarding the feasibility of achieving adequate blinding in randomized controlled trials of manual therapy. In other words, whether participants and outcome assessors can accurately perceive randomly assigned interventions is unclear. This feasibility trial was conducted as part of a doctoral epidemiology course at the University of Zurich, Switzerland. Within the practice-based context of the class and using a study population of healthy graduate students enrolled in the course, the investigators aimed to evaluate blinding of participants randomly assigned (similar to tossing a coin) to one of two manual therapy interventions (active versus control). The investigators also aimed to assess blinding among outcome assessors.

Conditions

Back Pain; Back Disorder; Back Pain, Low

Keywords

Methods; Manual therapy; Randomised trial; Back pain; Feasibility; Blinding assessment

Outcome Measures

Primary Outcomes (1)

• Blinding feasibility of participants, measured by the Bang blinding index.

  The Bang blinding index ranges from -1 to 1, with 0 representing satisfactory blinding. It can be interpreted as the proportion of participants correctly answering their allocated intervention within an intervention arm beyond chance. For the Bang BI, a score with an absolute value of ≤0.3 (i.e., -0.3 to 0.3) was deemed compatible with satisfactory blinding, although blinding scenarios (comparing blinding indices in active vs. control arms) were discussed. Participants were asked: "To which extent do you know which intervention you received?" and were given five possible answers: "I strongly believe I received the active intervention", "I somewhat believe I received the active intervention", "I somewhat believe I received the control intervention", "I strongly believe I received the control intervention", and "I do not know \[whether I received the active or control intervention\]".

  Immediately after the one-time intervention session (study day 1).

Secondary Outcomes (5)

• Blinding feasibility of participants, measured by the James blinding index.

  Immediately after the one-time intervention session (study day 1).

• Blinding feasibility of outcome assessors, measured by the Bang blinding index.

  Immediately after the one-time intervention session (study day 1).

• Factors contributing to perceived intervention arm allocation among study participants.

  Immediately after the one-time intervention session (study day 1).

• Factors contributing to perceived intervention arm allocation among outcome assessors.

  Immediately after the one-time intervention session (study day 1).

• Blinding feasibility of outcome assessors, measured by the James blinding index.

  Immediately after the one-time intervention session (study day 1).

Other Outcomes (9)

• Back function - self-reported flexibility, immediately before the one-time intervention session.

  Immediately before the one-time intervention session (study day 1).

• Back function - self-reported flexibility, immediately after the one-time intervention session.

  Immediately after the one-time intervention session (study day 1).

• Back function - self-reported ache, pain, discomfort in the upper back, immediately before the one-time intervention session.

  Immediately before the one-time intervention session (study day 1).

Study Arms (2)

Active manual therapy

EXPERIMENTAL

Active manual therapy intervention involved mobilization of the lumbar paraspinal musculature. With participants laying prone on a chiropractic table, the intervention provider administered hand-reinforced circumferential movements to six focal areas, using continuous ischemic compression strokes, and adjusting the pressure to participants' tolerability.

Other: Active manual therapy

Control manual therapy

SHAM COMPARATOR

Control MT intervention included light touch to six distal, broad areas of the thoracic region, with a synchronized breathing exercise.

Other: Control manual therapy

Interventions

Active manual therapy OTHER

Soft tissue mobilization of the lumbar paraspinal musculature (3 to 4 minutes).

Active manual therapy

Control manual therapy OTHER

Light touch and a breathing exercise (3 to 4 minutes).

Control manual therapy

Eligibility Criteria

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

You may qualify if:

• years of age or older
• enrolled in a doctoral-level epidemiology course at the University of Zurich, Switzerland.

You may not qualify if:

• serious pathology (i.e., cancer, severe scoliosis, inflammatory disease, infection, cauda equina syndrome or progressive motor deficit)
• history of spine surgery
• obvious contraindication to manual therapy (i.e., spinal fracture)

Sponsors & Collaborators

• Cesar A Hincapié, DC PhD: lead
• University of Zurich: collaborator

Study Sites (1)

University of Zurich

Zurich, Canton of Zurich, 8006, Switzerland

Location

Related Publications (1)

• Munoz Laguna J, Nyantakyi E, Bhattacharyya U, Blum K, Delucchi M, Klingebiel FK, Labarile M, Roggo A, Weber M, Radtke T, Puhan MA, Hincapie CA. Is blinding in studies of manual soft tissue mobilisation of the back possible? A feasibility randomised controlled trial with Swiss graduate students. Chiropr Man Therap. 2024 Jan 29;32(1):3. doi: 10.1186/s12998-023-00524-x.

  PMID: 38287417 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: Blinding was the primary outcome of interest. That said, except for intervention providers, every role was, by protocol, blinded to intervention assignment. To maintain blinding of participants, candidate participants were formally invited to participate by email, with a study information form that masked the blinding feasibility objective. The intervention providers were kept in a separate room and could not be blinded but were asked not to disclose the intervention group or the nature of the control MT component to participants, outcome assessors, data analysts, and other members of the study team.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Scientist and Head of Musculoskeletal Epidemiology Research

Model Details: Single centre, two-parallel group, blinding feasibility randomized controlled trial.

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 21, 2023
• Study Start: November 7, 2022
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Supporting information will be available once the manuscript is published in a peer-reviewed journal. Supporting information will be available indefinitely.
• Access Criteria: The principal investigator may request a brief description of the intended aims before sharing supporting information.

Locations

CH (1)