Efficacy of Group Exercise Program on Pain and Disability in Older People With Nonspecific Low Back Pain: Feasibility of a Randomized Controlled Trial.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Enrollment
- 60
- Primary Endpoint
- Feasibility of blinding the assessor
- Last Updated
- 4 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Feasibility of blinding the assessor
Time Frame: 8 weeks from randomization
Feasibility of blinding will be assessed by asking the assessor two questions at the end of the follow-up assessment: 1. Did you receive any information that indicated to you which group the participant was assigned to? 2. How did you receive information about group assignment? Assessor's guess regarding group assignment group will be recorded for each participant. The responses will be coded as correct or incorrect guess. The frequency and relative rates of 'Yes' and 'No' as the answer to the first question will be computed, as will the frequency and relative rates of correct and incorrect guesses. Finally, reasons for guesses will be recorded as verbatim and reported.
Difficulty in understanding the information provided by the physiotherapist
Time Frame: 8 weeks from randomization
Difficulty in understanding the information provided by the physiotherapist measured on a five-point categorical scale: Very easy, Easy, Neither easy nor difficult, Difficult, Very difficult
Eligibility and recruitment rates
Time Frame: 8 weeks from randomization
Eligibility and recruitment rates
Acceptability of random allocation to a treatment group
Time Frame: 8 weeks from randomization
Outcome assessor will ask the participants if random allocation to one of the two treatment groups is acceptable to the participants. Responses will be recorded as 'Acceptable', 'Not acceptable' or 'No preference'. The frequencies of each response will be computed separately for each treatment condition.
Understanding possible contamination between the groups
Time Frame: 8 weeks from randomization
Measures to assess: Have you talked to other participants in this study about the intervention they are receiving? Has your attitude towards the intervention changed after talking to the participant (s) in the other group? Are any of the participants in the other group aware of the type of intervention you are receiving in this study? The frequencies of the participants who responded affirmatively to each question will be computed separately for each treatment condition.
Adherence to treatment
Time Frame: 8 weeks from randomization
Adherence to treatment measured by frequency during the intervention
Satisfaction with the treatment
Time Frame: 8 weeks from randomization
All the participants of the intervention group will be asked to respond an adapted version of the MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care at 1 week following treatment. The question asked will be: 1. Did my physiotherapist carefully explain the treatments I received? 2. Did my physiotherapist treat me respectfully? 3. Did my physiotherapist answer all my questions? n general, am I completely satisfied with the services I received from my physical therapist? Responses to this question are made on a five-point categorical scale 1='completely disagree'; 2='Disagree'; 3= 'Neutral'; 4=' Agree'; 5=' Completely agree'). The frequency of response for each question will be analyzed
Secondary Outcomes
- Global perception of recovery(8 weeks from randomization)
- Level of physical activity(8 weeks from randomization)
- Frequency of falls(8 weeks from randomization)
- Pain intensity(8 weeks from randomization)
- Disability(8 weeks from randomization)
- Fear of falling(8 weeks from randomization)