Bowen Therapy for Chronic Non-specific Low Back Pain

NCT04861129 | Unknown

• 1 other identifier: RCT_BT_2021
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

There is emerging evidence that Bowen Therapy may improve musculoskeletal pain. While it can be an effective treatment strategy to enhance pain modulation; studies on the clinical effect are scarce. The aim of this study is to examine the effectiveness of Bowen therapy for people with chronic LBP on measures of pain, function, pain-related self-efficacy, and health related quality of life. Parallel-group randomized controlled trial (RCT) study will be employed. Pain Catastrophizing Scale (PCS) will be adopted as a screening test upon the randomization. A cutoff of more than 30 points will be used to represents clinically relevant level of catastrophizing. 46 participants with informed consent who meet the eligibility criteria of study are recruited and randomly assigned to one of two groups i.e. Bowen Therapy group and Sham Bowen Conventional Therapy group. Permuted block randomization is applied to control the key confounding variable of catastrophizing which is significantly associated with pain and disability in chronic LBP. Sequentially numbered, opaque, sealed envelopes (SNOSE) is used to ensure the allocation sequence before the group allocation. Double blinding of participants and outcome assessor will be adopted. Measurements are collected at the baseline (Week 0), post-intervention (Week 6) and at a 4-week follow-up (Week 10). The primary outcomes are pain as measured by Percentage of Pain Intensity Difference (PID) and pain relief scale (PRS). The secondary outcomes are measuring the physical functioning, self-efficacy in pain and HRQoL using Owestry Disability Index (ODI), Pain Self-efficacy Questionnaire (PSEQ) and SF-12 (HK) respectively. Intervention is provided weekly for 6 sessions lasting 30-40 minutes per treatment session. The experimental group will receive Bowen therapy according to ISBT Bowen Therapy®. The control group will receive a usual OT therapy with the same number of treatment session, treatment time, including back care advice and functional rehab training.

Conditions

Pain, Back

Keywords

Bowen therapy; Fascia; Low back pain

Outcome Measures

Primary Outcomes (5)

• Change of Percentage of Pain Intensity

  11-point scale by reporting a number from 0 - 10, with "0' representing "no pain" and "10" representing the "most intense pain imaginable". Therefore, the change in pain intensity is expressed as the percentage of pain intensity difference (%PID), which converts the raw score change to a proportional measure i.e. pain intensity difference between the assessments / Pain NRS at baseline assessment. (Score: 0 - 100%)

  Week 6 (compared to Week 0)

• Change of Percentage of Pain Intensity

  11-point scale by reporting a number from 0 - 10, with "0' representing "no pain" and "10" representing the "most intense pain imaginable". Therefore, the change in pain intensity is expressed as the percentage of pain intensity difference (%PID), which converts the raw score change to a proportional measure i.e. pain intensity difference between the assessments / Pain NRS at baseline assessment. (Score: 0 - 100%)

  Week 10 (compared to Week 0)

• Pain relief scale

  11-point scale with "0" representing "no relief of pain" and "10" representing "completely relieved" to measure the magnitude of change in pain intensity after the treatment. (Score: 0 - 100%)

  Week 0

• Pain relief scale

  11-point scale with "0" representing "no relief of pain" and "10" representing "completely relieved" to measure the magnitude of change in pain intensity after the treatment. (Score: 0 - 100%)

  Week 6

• Pain relief scale

  11-point scale with "0" representing "no relief of pain" and "10" representing "completely relieved" to measure the magnitude of change in pain intensity after the treatment. (Score: 0 - 100%)

  Week 10

Secondary Outcomes (9)

• Owestry Disability Index

  Week 0

• Owestry Disability Index

  Week 6

• Owestry Disability Index

  Week 10

• Chinese version of Pain Self-efficacy Questionnaire

  Week 0

• Chinese version of Pain Self-efficacy Questionnaire

  Week 6

Study Arms (2)

Bowen therapy group

EXPERIMENTAL

The experimental group will receive Bowen therapy according to ISBT Bowen Therapy® (Black \& Murray, 2005). It may include sequences 1, 4, 2, hamstrings (movements 1-6) and sacrum sequences in the prone position, and hamstrings sequence (7-18 movements) and 3 in the supine position,. The sequences may also include Bowen movements in the scalenes, trapezius, all erector spinae, sacro-iliac joint ligaments, gluteus maximus and medius, tensor fasciae latae, and gastrocnemius. The application of Bowen sequences is varied between sessions and participants depending on the presenting functional deficit and treatment response.

Procedure: Bowen therapy

Sham Bowen Therapy group

SHAM COMPARATOR

The control group will receive a sham Bowen therapy with the same number of treatment session, treatment time and rest time, that received in the experimental group. However, it consists of gently placing the hands over the areas just enough to maintain contact for the desired time as required by Bowen Therapy, without applying Bowen movement, which is considered the active principle of this technique.

Procedure: Sham Bowen therapy

Interventions

Bowen therapy PROCEDURE

Intervention is provided weekly for 6 sessions lasting 30-40 mins per treatment session

Bowen therapy group

Sham Bowen therapy PROCEDURE

Sham Intervention is provided weekly for 6 sessions lasting 30-40 mins per treatment session

Sham Bowen Therapy group

Eligibility Criteria

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

You may qualify if:

• ages between 18 and 65 years
• a diagnosis of low back pain with onset \> 12 weeks based on the evaluation by physician
• average pain intensity score of ≥ 3 on NPRS.

You may not qualify if:

• they have acute disc prolapse or protusion with neurological sign and symptoms in the past 3-months;
• bacterial spondylitis;
• Rheumatoid arthritis;
• ankylosing spondylitis;
• back pain secondary to bone malignancy
• spinal fracture;
• osteoporotic collapse;
• cauda equina compression
• prior spinal surgery;
• psychiatric disorder (e.g. psychosis / delusion);
• current pregnancy
• previous experience with Bowen therapy.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• United Christian Hospital: collaborator

Study Sites (1)

United Christian Hospital

Kwun Tong, Hong Kong

Location

MeSH Terms

Conditions

Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Andy S.K. Cheng, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinding of participants and outcome assessor will be adopted. Independent assessors who conduct outcome measures are blinded to the group assignments, so allocation concealment and masking can be preserved throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 17, 2021
• First Posted: April 27, 2021
• Study Start: April 19, 2021
• Primary Completion: September 30, 2021
• Study Completion: June 30, 2022
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)