Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04861129 |
| Other study ID # |
RCT_BT_2021 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 19, 2021 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
April 2021 |
| Source |
The Hong Kong Polytechnic University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Low back pain (LBP) is one of the most common condition resulting in socioeconomic burden on
health care systems. LBP is defined as pain, muscle tension, or stiffness in the area between
the lower posterior margin of the rib cage and the horizontal gluteal fold with or without
leg pain. Acute LBP is defined as pain that lasts less than 6 weeks, sub-acute LBP lasts for
6 to 12 weeks, and chronic LBP lasts for longer than 12 weeks. Prevalence study in Hong Kong
showed that an estimated 57.1% and 42.1% of the population reported of LBP at least once in
their life time and at least once within the past year respectively. In the past decades,
several multidisciplinary clinical guidelines were developed in Canada, UK and US for the
management of LBP which aimed to promote consistent best practice in patient care. All the
guidelines recommended exercise therapy as one the strategy in terms of non-pharmacological,
non-invasive management. The National Institute for Health and Care Excellence (NICE)
guideline suggested that group exercise programme (biomechanical, aerobic, mind-body or a
combination of approaches) should be provided for people with single episode or flare-up of
LBP with or without sciatica. Whereas manual therapy could be offered only alongside
exercise. Both US and Canadian guidelines advocated similar recommendations. However, none of
the guidelines were able to specify which forms of manual therapy is superior for the
management of chronic LBP. Bowen therapy is a complementary and alternative medicine
involving light touch over the fascial, specific muscles, tendons and connective tissues to
improve flow of blood, lymph and energy. It is one of the fascial techniques which aims to
release the muscle tension, improve pain and restore function. Bowen therapy was named after
Tom Bowen (1916-1982) and also known as Bowen Technique, Bowenwork and Bowtech which are
interchangeable in the literature. It promotes connective tissues to slide over each other
and improve the afferents responses in response to dysfunction. While Bowen therapy can be an
effective treatment strategy to enhance pain modulation; studies on the mechanism of action
of Bowen therapy and its clinical effect are scarce.
In most instances, the basic Bowen moves are applied using the fingers and thumbs. It
involves taking a slack over skin, applying a gentle non-invasive pressure over muscles,
tendon and fascia. Other techniques including fast release, gentle stretching, repetitive
squeezing will be used according to the therapist's assessment. Bowen therapy could
facilitate tissue hydration and recoiling properties of fascia. It was suggested that Bowen
moves in slow release can activate various sensory receptors (e.g. Merkel's Discs, Meissner's
corpuscles and Free Nerve Endings) and mechanoreceptors (e.g. Golgi tendon organs, Ruffini
endings and Interstitial receptors). For the Bowen moves in fast release, Pacini corpuscles
can be activated. The activation of various Golgi tendon organs can lower the sympathetic
nervous system (SNS) activity. Furthermore, interstitial receptors stimulated by Bowen moves
can also lower SNS and increase vagal tone to achieve the deep relaxing effect and reduction
of nerve pressure. It is suggested to adopt different treatment technique of approach to
target the dysfunction arising from various types of fascia. The deep fasciae and the
epymisium are related to adjustment in coordination, proprioception, balance, myofascial
pain, and muscle cramps. According to different anatomical locations and fascial tissue,
enough pressure with manual deep friction is required in order to reach the deep fasciae and
epymisium. It can explain why some Bowen moves (e.g. Hamstring sequence on biceps femoris)
using elbow instead of fingers to exert enough pressure on the soft tissue. Yet in most
instances, light massage, which can be achieved in most of the basic Bowen moves, are
adequate to address the pain caused by superficial fascia. The Bowen moves also follows a
planned sequence of stimulation based on the evidence on myofascial continuity. In Bowen
therapy session, two-minute pauses are applied between a set of Bowen moves, that muscle
spindles are activated upon the stretch on the muscle fibers. It can be explained by the
general pain sensitization of nerve pathways commonly found in people with chronic pain, and
so two-minute waiting time allows the body to make appropriate adjustments to re-align and
balance, through the mediation at the spinal cord and central nervous system.
Although clinical practice implies that Bowen therapy is a useful technique, particularly in
relation to improved pain, joint mobility and functional status; there is still little
published research in the literature about the clinical effect of Bowen therapy. Moreover,
majority of the studies reviewed lack of control group design and methodological issues,
including small sample size, poor sampling method, inadequate information of study sample,
and lack of standardized measurement tools. More vigorous and stringent research design is
warranted for the future research study.
