Preference, Exercise Therapy Adherence and Efficacy Low Back Pain

NCT03984864 | Unknown

• 1 other identifier: AU-HEA-SS-20190522
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Low back pain, mainly nonspecific (NSLBP) is a major cause of pain and disability worldwide. Exercise therapy (ET) is considered as the first line treatment, and it is one of the treatment modalities most commonly used by physiotherapists. Yet, ET is reliant on the adherence of patients to its various components. Research has demonstrated a positive relationship between adherence to rehabilitation programs and recovery from a variety of musculoskeletal conditions. Therefore, factors that strengthen adherence to ET may increase its efficacy for NSLBP. Converging evidence from recent studies suggest that control and choice may increase adherence to various treatments. Therefore, the purpose of this study is to evaluate the effect of patient choice and preference on adherence and efficacy of exercise for recovery from NSLBP. Design: Matched case control study. Participants: Fifty subjects with chronic (\>3 months) NSLBP. Twenty-five participants will be allocated to exercise by preference group, and 25 aged and gender controls will be allocated to exercise group. Inclusion criteria:

• 150 minutes of moderate-intensity aerobic physical activity throughout the week or at least 75 minutes of vigorous-intensity aerobic physical activity throughout the week or an equivalent combination of moderate- and vigorous-intensity activity.
• Muscle-strengthening activities should be done involving major muscle groups on 2 or more days a week. Procedure: After initial assessment, participants in the intervention group will be asked to choose 3-4 items from a list of 10 general exercises - intended for treatment of low back pain. Each matched participant in the control group will receive the same exercise (without the option to choose). Participants will be instructed to perform their exercises three times a week, for a period of four weeks (12 sessions total). Outcomes: Oswestry Disability Index (ODI) Henry-Eckert Performance Assessment Tool (HEPA) Both measurements will be taken on the first and last meeting. Additionally, each participant will fill a personal weekly exercise log (selecting between complete \\ incomplete \\ lack of execution) - sent by e-mail.

Conditions

Low Back Pain, Recurrent

Outcome Measures

Primary Outcomes (1)

• Change in Oswestry Disability Index (ODI)

  Patient-completed questionnaire consisted of 10 items which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. Each item consists of 6 statements scored from 0 to 5 (score of 0 indicates less disability). The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible * 0% -20%: Minimal disability * 21%-40%: Moderate Disability * 41%-60%: Severe Disability * 61%-80%: Crippling back pain * 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms Minimally clinical important difference (Johnsen et al. BMC Musculoskelet Disord. 2013) = 12.88, (sensitivity 88%, specificity 85%)

  Pre intervention/ At the end of the intervention (week four)

Secondary Outcomes (2)

• Henry-Eckert Performance Assessment Tool (HEPA)

  At the end of the intervention (week four)

• Weekly exercise log

  At the end of the intervention (week four)

Study Arms (2)

Exercise therapy Chosen

EXPERIMENTAL

Other: Exercise therapy

Exercise therapy no Chosen

ACTIVE COMPARATOR

Other: Exercise therapy

Interventions

Exercise therapy OTHER

3-4 items from a list of 10 general exercises - intended for treatment of low back pain

Exercise therapy Chosen; Exercise therapy no Chosen

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Non-specific low back pain (pain or discomfort in the lumbosacral area, with or without symptoms to the lower extremities), diagnosed by general physician or orthopedic surgeon.
• Age 18-35
• Chronic pain (greater than 3 months' duration).

You may not qualify if:

• Specific cause for LBP (rheumatic diseases, tumors, fractures, fibromyalgia, previous spinal surgery, pregnancy, low back pain after car or work accidents).
• Previous (last three years) ET treatment for NSLBP.
• Regularly performing exercise more than WHO's recommendation:
• minutes of moderate-intensity aerobic physical activity throughout the week or at least 75 minutes of vigorous-intensity aerobic physical activity throughout the week or an equivalent combination of moderate- and vigorous-intensity activity.
• Muscle-strengthening activities should be done involving major muscle groups on 2 or more days a week.

Sponsors & Collaborators

• Ariel University: lead

Study Sites (1)

Ariel University clininc

Ariel, Israel

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• shmuel springer

  Ariel University

  PRINCIPAL INVESTIGATOR

• Yhonatan Levi

  Ariel University

  STUDY DIRECTOR

Central Study Contacts

shmuel springer

CONTACT

+97239066330; shmuels@ariel.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Physical Therapy Department

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 13, 2019
• Study Start: July 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

IL (1)