Efficacy of Group Exercise Program in Older People With Nonspecific Low Back Pain

Federal University of the Valleys of Jequitinhonha and Mucuri

Status: Unknown

Conditions: Back Pain; Low Back Pain

Treatments: Other: Group-Based Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04915547

30042021

Details and patient eligibility

About

The main objective of the study is to assess the feasibility of a randomized clinical trial that investigates the effects of an 8-week group exercise program on pain, disability, fear of falling, overall impression of recovery, frequency of falls and level of physical activity in elderly people with nonspecific low back pain.

Full description

The main objective of the study is to assess the feasibility of a randomized clinical trial that investigates the effects of an 8-week group exercise program on pain, disability, fear of falling, overall impression of recovery, frequency of falls and level of physical activity in elderly people with nonspecific low back pain. The evaluation of feasibility will be related to: (1) blinding the evaluator to allocate the groups; (2) eligibility and recruitment rates; (3) acceptability of random allocation to a group; (4) possible contamination between groups; (5) adherence to treatment; (6) satisfaction with the treatment; and (7) difficulty in understanding the information provided by the physiotherapist.

Enrollment: 60 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Older people aged 60 years old or over who have nonspecific LBP, defined as pain below the costal margin and above the lower gluteal folds, with or without referred leg pain for at least 3 months.
• Disability with score 4/24 in Roland-Morris Disability Questionnaire or higher and persistent back pain of pain 3/10 or higher.

Exclusion criteria

• Suspected or confirmed serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome/widespread neurological disorder);
• Radiculopathy (i.e. presence of 2 of the 3 following criteria: strength, reflex or sensation alterations compatible with lumbosacral nerve root compression);
• Previous history of spinal surgery; scheduled for major surgery during the study or at the follow up period;
• Any of the contraindications to exercise listed on page 103 of the American College of Sports Medicine (ACSM) guidelines.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group-Based Exercise

Experimental group

Description:

The group-based exercise (GBE) programme will be delivered by a physiotherapist. The GBE comprises three sessions per week of group-based exercise in a local community centre, for 8 weeks.

Treatment:

Other: Group-Based Exercise

Control Group

No Intervention group

Description:

Participants randomly allocated to the control group will remain on a waiting list. In addition, weekly contact will be made to ensure that they do not start treatment during the study protocol. After the end of the study, participants randomly allocated to the control group will receive the same intervention as the Group-Based Exercise.