Chronic back pain rehabilitation in small groups: pain, disability and function a quasi-randomized trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000306516
• Date of registration: 01/04/2015
• Prospective Registration: Yes
• Primary sponsor: Giacomo Carta
• Public title: Chronic back pain rehabilitation in small groups: pain, disability and function a quasi-randomized trial
• Scientific title: In patients with chronic back pain is rehabilitation in small groups following the international guidelines as good or better than classic approach with back school (postural education, strengthening exercises, stretching exercises) for relief of pain, reduction of disability, and increase of function
• Date of first enrolment: 03/05/2015
• Target sample size: 96
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12615000306516.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

Italy

Contacts

• Name: Dr Giacomo Carta

• Name: Dr Giacomo Carta

Key inclusion & exclusion criteria

Inclusion criteria: Male and female participants with chronic back pain. This group excludes those with oncological disease or neurological progressive diseases and dementia(as assessed from described history of participants), because of possible interaction with diseases problems related , which introduces confounding factors for interpretation of the results.
Participants will have had LBP for at least 12 weeks and have provided written informed consent confirming
their participation.

Exclusion criteria: Participants will be excluded for the following reasons: presence of severe postural abnormality or neuromuscular disorder, previous diagnosis of pathology (confirmed by previous magnetic resonance imaging or radiograph).
Participants must not have engaged in any specific rehabilitation program in the last 3-months, and
must not be regularly seeing a physiotherapist or any spinal manipulation practitioner.

Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

chronic back pain ;
chronic back pain

Physical Medicine / Rehabilitation - Physiotherapy

Musculoskeletal - Other muscular and skeletal disorders

Intervention(s)

2-week exercise rehabilitation program. Back School based exercise involving stretching of back muscles, exercise of abdomen strenghtening, postural education, floor based exercise. Back School home-based exercises (the same exercises performed during treatment sessions) are reported in a book given at the end of the treatment. Evidence based exercise involving progressive exposure (with a progressive increase in repetitions and coordination and decrease of balance till fatigue), aerobic global exercise (involving the muscles of both legs and of the back in the way to increase the heart beat from the one at rest). Evidence based home-based exercises involves global aerobic exercises floor based exercises and auto-mobilization of peripheral nervous system, those exercises will be taught to the patients during the treatment sessions.
Prescription is 5 x 1/2 hours sessions per week for 2-weeks. All directly supervised from the physiotherapist in a group format (5 people per group session). All sessions will be performed in a outpatient service of the public health system. No intervention group will completes both the back and evidence based exercises. Adherence to the intervention will be assessed through the presences to the treatment sessions and an adherence scale at follow-up assessment.

Primary Outcome(s)

Pain intensity (Verbally administred Numerical Pain Rating Scale)

[Baseline (pre), 2-weeks (post program) and 3 month (follow up)]

Disability (Roland Morris Disability Questionnaire)[Baseline (pre), 2-weeks (post program) and 3 month (follow up)]

Functioning (SF-36)[Baseline (pre), 2-weeks (post program) and 3 month (follow up)]

Secondary Outcome(s)

number of exercise remembered will be assessed during the administration of the scales at follow up in a written form.

"Report here how many exercises you remeber from those learnt during the treatment sessions_________"[3 month (follow up)]

Adeherence to the Physical therapist indications on home exercises (SIRAS) [3 month (follow up)]

other health system access for unresolved back pain will be assessed during the administration of the scales at follow up in a written form.

"Report here how many other accesses to the health system you have done for your unresolved back pain after the treatment sessions_________"

[3 month (follow-up)]

Secondary ID(s)

none

Source(s) of Monetary Support

None

Ethics review

Status: Not approved
Approval date:
Contact:

Isituti Clinici di Perfezionamento