The short term effects of Gravity Relief Mobilisation massage therapy on chronic low back pain.

The intervention (phase 'B') involves attendance to a series of treatment sessions over 12 weeks and no further treatments over a follow up sub-phase of 12 weeks. The follow up period cannot be considered a seperate withdrawal phase because potential carry over effects are not expected to return to base line levels immediately after ceasing treatments. The treatment sessions consist of a massage therapy based clinical intervention that a utilises a process approach to rehabilitation (Lederman, 2015). The intervention is comprised of both manual therapy and educational components that address the musculoskeletal system. The main activity is a novel form of myofascial release type indirect manual therapy that we have called Gravity Relief mobilisation (GRM). GRM induces muscle contraction and relaxation to gently mobilise tissues and joints. This is achieved indirectly by the amelioration of gravity, activating the mobilisation of nerves, muscles, connective tissues, and joints. The mechanism at work induces reflex like non-volitional motor activity. Coupled to the amelioration of gravity are holding techniques and angular cross stretches that are applied with the hands gently to the soft tissues . Preceding application of GRM, gliding and kneading massage techniques are used to induce a feel-good relaxation effect. During the treatment if appropriate breathing mechanics are discussed and practiced at the time thoracic and cervical regions are being addressed. The treatment sessions will conclude with exercise and stretching advice and salient postural problems are attended to with education about good standing posture and how this may be achieved. In addition, movement education of basic movements is incorporated, if indicated by pain or difficulty with daily activities. Follow up advice to practice the exercises at home is given to consolidate treatment session gains. The interventions manual therapy components are applied with the participant lying comfortably on a massage table, they may be undressed down to their underwear for massage contact with the skin. The table is adjusted for tilt and bolsters are used for maximal comfort. Participants will be draped at all times with only the body region being worked on exposed, buttocks and chest areas will remain covered at all times. The participant may choose to receive the treatment fully dressed wearing light flexible clothing. Participant comfort and sense of security is prioritised. The intervention consists of a minimum of four and maximum of 12 treatment sessions delivered over the course of 12 weeks. The treatment sessions will be booked a maximum of three weeks apart and a minimum of one week apart. This will be negotiated between the participant and the therapists recommendations, reflecting clinical practice procedures. An increase in pain lasting for 24-72 hours, is sometimes observed after a treatment session, therefore follow ups are scheduled according to the response and recovery from previous treatments. This ensures that any adverse effects will not interfere with important roles and responsibilities of the participant. Each treatment session is between 1 - 1 1/2 hours duration. The length of the session is influenced by client tolerance for lying on the table. Treatment times for participants who have allodynia or experience distress in static positions will be titrated. Sessions will start at no longer than 60 minutes including assessment. If the response and recovery is acceptable to the client the next session time will be increased by 15 minutes until the 90 minute maximum is reached. The intervention has been developed and will be delivered by a qualified and Massage New Zealand (MNZ) Level 7 registered massage therapist with 12 years clinical practice experience. All treatment sessions are being video recorded and a random selection viewed for the purpose of assessing fidelity. Observer XT software will be used to code the practitioners observable behaviours, and the resulting data assessed against a list of required behaviours. The required behaviours correspond to a detailed treatment manual and are bound by minimum and maximum durations. Intervention fidelity is being assessed by another MNZ Level 7 registered massage therapist who holds a Masters Degree in Health Science and works as a research fellow. This therapist is the treatment manuals co-author and will be trained in the novel GRM technique before the participants cross over to the intervention phase. As the therapist conducting the fidelity assessment is already highly qualified in massage and rehabilitation studies, only GRM training is needed. Training will consist of demonstration of GRM techniques on a volunteer by the interventions developer, following the techniques as they are outlined in "Chronic Low Back Pain Treatment manual V1.0 Characterisation of a Novel Intervention"(Verhagen and Brown, 2017). The treatment manual describes in detail how GRM is applied to each of the body regions. The regions are specified as: head (cephalic), neck (cervical), back (dorsal- below neck to below waist not including shoulders), ribs or thoracic (trunk), pelvis, shoulders-arms-hands (upper extremity), hips-knees-feet and ankles (lower extremity). The abdomen is not targeted in this intervention. The GRM training will consist of an hour demonstration and an hour of practice.