Clinical trial NCT04915547: Efficacy of Group Exercise Program in Older People With Nonspecific Low Back Pain
Official title: Efficacy of Group Exercise Program on Pain and Disability in Older People With Nonspecific Low Back Pain: Feasibility of a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Back Pain
Lead sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of blinding the assessor
timeFrame: 8 weeks from randomization
measure: Eligibility and recruitment rates
timeFrame: 8 weeks from randomization
measure: Acceptability of random allocation to a treatment group
timeFrame: 8 weeks from randomization
measure: Understanding possible contamination between the groups
timeFrame: 8 weeks from randomization
measure: Adherence to treatment
timeFrame: 8 weeks from randomization
measure: Satisfaction with the treatment
timeFrame: 8 weeks from randomization
measure: Difficulty in understanding the information provided by the physiotherapist
timeFrame: 8 weeks from randomization
Secondary outcomes:
measure: Pain intensity
timeFrame: 8 weeks from randomization
measure: Disability
timeFrame: 8 weeks from randomization
measure: Fear of falling
timeFrame: 8 weeks from randomization
measure: Level of physical activity
timeFrame: 8 weeks from randomization
measure: Global perception of recovery
timeFrame: 8 weeks from randomization
measure: Frequency of falls
timeFrame: 8 weeks from randomization
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of the Valleys of Jequitinhonha and Mucur
name: Letícia Soares Fonseca
role: PRINCIPAL_INVESTIGATOR
References: