Clinical trial NCT04554784: Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia
Official title: A Prospective Randomized Control Trial on the Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: Bowen Therapy
conventional pain management
Lead sponsor: Alice Ho Miu Ling Nethersole Hospital
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2020-09-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of Pain Score
timeFrame: 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:
measure: Change of Endurance strength test of lower extremities
timeFrame: 3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th weeks)
measure: Change of Endurance strength test of upper extremities
timeFrame: 3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th weeks)
measure: Change of Brief pain inventory-Short Form (BPI)
timeFrame: 3 time points (0 week, 12th week and 24th week after obtaining consent)
measure: Change of Hospital anxiety and depression scale (HADS)
timeFrame: 3 time points (0 week, 12th week and 24th week after obtaining consent)
measure: Change of 36-item Short form Survey (SF-36)
timeFrame: 3 time points (0 week, 12th week and 24th week after obtaining consent)
measure: Jenkins Sleep Evaluation Questionnaire (JSEQ) for sleep
timeFrame: 3 time points (0 week, 12th week and 24th week after obtaining consent)
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Pain Management Centre (NTEC); PWH/ AHNH
state: New Territories
Study officials:
affiliation: Pain Nurse (Registered Nurse)
name: Pik Yu Chen, RN, BSc, MSc
role: PRINCIPAL_INVESTIGATOR
References: