Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia

NCT04554784 | Unknown

• 1 other identifier: Bowen (fibro) 2020.357
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective, randomized study is to explore the effectiveness of Bowen Therapy in pain management for patients with fibromyalgia. In Hong Kong, Bowen Therapy is a non-invasive technique and one of the treatment modalities adopted by Occupational Therapists. Bowen Therapy uses specific sequences of gentle cross-fibre moves over muscles, tendons, ligaments, and fascia to stimulate or improve the flow of blood and lymph, and thus activate the body's healing mechanisms that enhances tissue repair. As a result, it can lessen pain and tension, restore more optimal body function, and subsequently alleviate emotional and psychological stress associated with the pain. Bowen Therapy is widely recognized and utilized worldwide for acute and chronic health conditions from new-born to the elderly, both mobilized and bed-ridden patients with no documented evidence to show it has caused any harm or adverse effects. There are two study groups in this study and patients will be randomized and allocated to either one. One group (Control group) will continue receiving conventional treatment; while another group (Bowen group) will receive 8 sessions of Bowen therapy. The investigators hypothesize that Bowen Therapy is superior to the conventional pain treatment for patients with fibromyalgia.

Conditions

Fibromyalgia

Keywords

Bowen Therapy; conventional pain management

Outcome Measures

Primary Outcomes (1)

• Change of Pain Score

  The pain score in Numeric Rating Scale (0-10) for both groups of patients, which 0= no pain to 10=worst pain.

  3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th weeks)

Secondary Outcomes (6)

• Change of Endurance strength test of lower extremities

  3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th weeks)

• Change of Endurance strength test of upper extremities

  3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th weeks)

• Change of Brief pain inventory-Short Form (BPI)

  3 time points (0 week, 12th week and 24th week after obtaining consent)

• Change of Hospital anxiety and depression scale (HADS)

  3 time points (0 week, 12th week and 24th week after obtaining consent)

• Change of 36-item Short form Survey (SF-36)

  3 time points (0 week, 12th week and 24th week after obtaining consent)

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Conventional pain treatment.

Other: Conventional

Bowen

ACTIVE COMPARATOR

Patients will be referred to Occupational Therapist for Bowen therapy.

Procedure: Bowen

Interventions

Conventional OTHER

Patients' condition will be continue managed by pain specialists with regular follow-ups and continue patients' active concurrent pain treatment such as taking analgesics, physiotherapy, massage, chiropractor.

Conventional

Bowen PROCEDURE

Patients will be referred to Occupational therapist for Bowen Therapy. There will be a week washout period before the start of Bowen Therapy. During a week washout period and study period, patients can continue taking analgesia, but advised to stop the concurrent treatments which can affect the deep tissue such as massage, physiotherapy, and chiropractic to minimize the counteracting effect on the Bowen's action. During a Bowen Therapy session, patients will lie relaxed on the examination couch wearing loosely fitting clothing or only the affected area being exposed. The therapist applies a series of gentle movements across the body. The gentle movements focus on a body of muscle, tendon or nerve and release tension through the nerve within the area. Each session will last for 30 minutes to an hour. After each session, the next appointment will be given to patients. The first four sessions will be scheduled on weekly basis, and the remaining four on biweekly session.

Bowen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Widespread pain index (WPI) ≧7 and symptom severity (SS) scale score ≧5 or WPI between 3 and 6 with SS scale score ≧9. The WPI includes evaluation of tender points at 19 regions. Tender point count (TPC) is examined by application of approximately 4 kg/cm2 pressure with the tip of the thumb on those regions.
• Symptoms have been present at a similar level for at least 3 months.
• Patient does not have any disorder that would otherwise explain the pain
• Agrees to participate in the study and agree to discontinue other alternatives treatments except in conditions otherwise approved by the investigators.

You may not qualify if:

• Patient refusal
• pregnancy
• assessed to be contraindicated to participate by pain specialists due to the presence of other co-morbidities or conditions
• underlining disease that affect mobility of upper limb and lower limb
• known severe psychiatric illness
• known malignancy, skin disease, infectious disease, severe cardiovascular disease, patients taking anti-coagulants
• enrolled in other studies
• refuse to temporarily discontinue concurrent treatment or intervention as pain management during the study period e.g. alternative medicine, physiotherapy, chiropractor

Sponsors & Collaborators

• Alice Ho Miu Ling Nethersole Hospital: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Pain Management Centre (NTEC); PWH/ AHNH

Shatin, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Pik Yu Chen, RN, BSc, MSc

  Pain Nurse (Registered Nurse)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Winnie Samy, RN, BN, MSc

CONTACT

+85235052734; wsamy@cuhk.edu.hk

Pik Yu Chen

CONTACT

+85255696172; pro910@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 1. Investigator will be blinded and responsible for obtaining informed consent. 2. Outcome Assessor who will be responsible to perform the Endurance Strength Test (EST) and assist patients in completing questionnaires, will be blinded to measure the EST during the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pain nurse (Registered Nurse)

Model Details: Patients will be randomly allocated to receive either conventional treatment or Bowen Therapy, following the computer-generated sequence (1= Control, 2= Bowen Therapy). The randomization sequence will be prepared by a research assistant, who will not take part in the study. The randomization sequence will be placed in a brown, and sealed envelopes: Group 1 (n= 40): Control (conventional treatment); and Group 2 (n= 40): Bowen Therapy.

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 18, 2020
• Study Start: September 6, 2020
• Primary Completion: December 6, 2022
• Study Completion: September 6, 2023
• Last Updated: February 16, 2022

Record last verified: 2022-02

Locations

HK (1)