Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia

NCT ID: NCT04554784

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-06
• Study Completion Date: 2023-09-06

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.

Detailed Description

This study is going to look at the effectiveness of Bowen Therapy in pain management for patients with fibromyalgia. 80 patients with fibromyalgia attending pain management clinic will be recruited at Alice Ho Miu Ling Nethersole Hospital after informed consent. They will be randomized into either group (control group or Bowen group). Control group will continue receiving conventional treatment such as follow-ups by pain specialists, taking analgesia, physiotherapy. Bowen group will need to attend 8 sessions of therapy. All subjects will be evaluated at 12th week and 24th week after signing the consent.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conventional

Conventional pain treatment.

Group Type: ACTIVE_COMPARATOR

Conventional

Intervention Type: 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.

Bowen

Patients will be referred to Occupational Therapist for Bowen therapy.

Group Type: ACTIVE_COMPARATOR

Bowen

Intervention Type: 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.

Interventions

Conventional

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.

Intervention Type: OTHER

Bowen

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

Alice Ho Miu Ling Nethersole Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ms Pik Yu CHEN

Pain nurse (Registered Nurse)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pik Yu Chen, RN, BSc, MSc

Role: PRINCIPAL_INVESTIGATOR

Pain Nurse (Registered Nurse)

Locations

Pain Management Centre (NTEC); PWH/ AHNH

Shatin, New Territories, Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Winnie Samy, RN, BN, MSc

Role: CONTACT

wsamy@cuhk.edu.hk

+85235052734

Pik Yu Chen

Role: CONTACT

pro910@cuhk.edu.hk

+85255696172

Facility Contacts

Pik Yu Chen, RN, BSc, MSc

Role: primary

pro910@cuhk.edu.hk

55696031

Other Identifiers

Bowen (fibro) 2020.357

Identifier Type: -

Identifier Source: org_study_id