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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000269538
• Date of registration: 23/03/2015
• Prospective Registration: Yes
• Primary sponsor: The University of Sydney
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 10/06/2015
• Target sample size: 108
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000269538.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Martin G Mackey

• Name: Mr John Petrozzi

Key inclusion & exclusion criteria

Inclusion criteria: Adults who are present for chiropractic or physiotherapy care with a new episode of non-specific lower back pain of more than three months duration.
Exclusion criteria: Participants will be excluded if they have been diagnosed with serious spinal pathology (fracture, malignancy, infection, inflammatory disorders, canal stenosis or cauda equina syndrome, spinal cord injury), spinal nerve compromise (determined by the presence of two or more corresponding neurological signs such as dermatomal paresthesia or paresthesis, diminished absent deep tendon reflexes), have undergone spinal surgery in the past 12 months, are pregnant, have a compensation claim related to their back condition, are not able to independently complete English language questionnaires, or are not able to independently use a computer. Score in the low or high risk group on the STarT Back Tool.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

Chronic low back pain;
Chronic low back pain

Musculoskeletal - Other muscular and skeletal disorders

Intervention(s)

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 defin

Primary Outcome(s)

Pain Self Efficacy Questionnaire (PSEQ)(Nicholas, 1989)
[At baseline and at 2, 6, and 12 months from enrolment]

Secondary Outcome(s)

Patient Specific Functional Scale (PSFS) (Nicholas MK. 1989)[At baseline and at 2,6 and 12 months from enrolment ]

Depression Anxiety and Stress Scale (DASS21) (Lovibond, 1995)[At baseline and at 2, 6, and 12 months from enrolment]

Roland Morris Disability Questionnaire (Roland & Morris, 1983)[At baseline and at 2, 6, and 12 months from enrolment]

Pain intensity Numerical Rating Scale (Jensen MP, 1992a)[At baseline and at 2, 6, and 12 months from enrolment]

Pain Catastrophizing Scale (PCS) (Sullivan, Bishop, & Pivik, 1995)
[At baseline and at 2, 6, and 12 months from enrolment]

Work Ability Inventory (WAI) (Tuomi, Oja 1998)[At baseline and at 2, 6, and 12 months from enrolment]

Secondary ID(s)

Nil

Ethics review

Status: Approved
Approval date:
Contact:

The University of Sydney Human Research Ethics Committee