Does an online psychological intervention improve self-efficacy and disability in people also receiving Multimodal Manual Therapy for chronic low back pain compared to Multimodal Manual Therapy alone? Design of a randomized controlled trial

Participants will be randomly allocated to one of two groups. Group 1 Multimodal Manual Therapy (Control): Participants in this group will receive Multimodal Manual Therapy treatment (MMT) only. MMT refers to treatment that is centred around manual therapies but also employs best practice primary care and is supported by therapeutic exercises. The manual therapy component of MMT may involve high-velocity, low-amplitude thrust manipulation, non-thrust joint mobilization, or soft tissue massage. The high-velocity, low-amplitude thrust techniques will involve a carefully directed, gentle but quick thrust through the mechanical plane of the spine or pelvic joints that may or may not be accompanied by an audible ‘pop’ or cavitation sound. These techniques may be performed with the therapist’s hands or with the assistance of a device such as a drop-piece table. The non-thrust mobilization techniques will involve passive oscillatory movements of the spine or pelvic joints through normal ranges of motion. Soft tissue massage techniques will be directed at the muscles of the back and pelvis and perfomed with the therapist’s hands or a vibrating massage device. All participants will receive components of best practice primary care that involves reassurance, advice about symptom management and encouragement to remain active. MMT may be supported by exercises that may include general physical conditioning, or specific exercise programs that address; symptom management, or mobility, strength or motor control impairments. Other treatment modalities that are used by chiropractors and physiotherapists that are not endorsed by practice guidlines (e.g. therapeutic ultrasound, transcutaneous electrical nerve simulation, heat therapy, etc) will not be included in the definition of MMT. All participants in the MMT group will receive manual therapy. The selection of other supportive treatment modalities will be determined by the chiropractor or physiotherapist according to their clinical judgment. Treatments will either be performed by a registered chiropractor or physiotherapist who has more than 5 years of clinical experience. Participants will receive up to 12 treatments over a period of 8 weeks. The practitioner may elect to use fewer treatments in cases where the participant has experienced significant improvement or has developed adverse effects that warrant stopping care. The definition of an adverse effect (event) is either: 1) a new related complaint which was not present at baseline or previous visit, or 2) a worsening of the presenting complaint. Adverse events will be measured using a similar questionnaire as in the side effects of chiropractic treatment study by Leboeuf-Yde et al. and will be carried out at the 8 week follow up interval. Group 2 MoodGym combined with Multimodal Manual Therapy (Intervention): Participants in this group will receive the same MMT as Group 1; however, this group will also complete the MoodGYM program. Participants will complete one module of the MoodGYM program per week over a five week period. The content of MoodGYM involves the completion of five modules of 20- to 40-minutes duration. The modules use various tools such as interactive games, mood assessments, and downloadable relaxation audio file. The modules focus on aspects of cognitive behaviour therapy, including cognitive restructuring, the relationship between thoughts and feelings, behavioural activation, relaxation, and problem solving. Participants are encouraged to continue their leanings in their daily life by applying principles taught in the modules. Participants in the MoodGYM group will set up a username and password at the time of enrolment and will be given an instruction manual for their five-week online MoodGYM program. Participants will also receive a weekly telephone reminder, to enhance adherence with the MoodGYM program and avoid attrition. Attrition has been identified as an issue in similar studies and higher completion rates were achieved with occasional telephone or email contact. No additional counseling or treatment advice will be provided with the reminder telephone calls. Participants who report distress as a result of using MoodGym will be offered referral to a clinical psychologist. Participants in both groups will be given a follow-up appointment schedule for their 8-week course of MMT. The MMT will be provided by a chiropractor or a physiotherapist using techniques listed above which are inaccordance with International Clinical Practice Guidelines for chronic LBP.