Clinical trial NCT04135131: Efficacyof Pilates Exercises in Lowback Pain
Official title: Comparison of The Efficacy of Pilates Exercises and Home Exercise Program on Pain, Functional Level and Thickness of Core Muscles in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Physical Therapy
Pilates
Keywords: Abdominal Muscles
Exercise Therapy
Low back pain
Paraspinal Muscles
Lead sponsor: Haydarpasa Numune Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized-single blinded study
Primary purpose: SCREENING

Brief summary: OBJECTIVE: To investigate the effects of pilates exercise by training the muscles responsible for core stabilization in patients with chronic non-specific low back pain (CNLPB); considering pain, functional level, depression, quality of life, and muscle thickness measured by Ultrasound Imaging and to compare it with home based exercise.

MATERIAL AND METHODS: A prospective, randomized-single blinded study included 60 female patients with CNLBP aged 18-60 years. Patients were randomized into 2 groups. The first group (n=30) performed pilates 3 days/week for 8 weeks. Sessions lasted about one hour and supervised by a pilates trainer. The second group (n=30) was given home exercise program 3 times/week for 8 weeks, each session lasting one hour. The evaluations were made both at the beginning and end of the treatment. Evaluation parameters included VAS (visual analogue scale), Oswestry Disability Index, Qubec Disability Scale, Short Form-36 (SF-36), Beck Depression Questionnaire, sit and reach test, Modified Schöber test, sit up test. Multifidus and abdominal muscle thickness were measured by Ultrasonographic Imaging.

Detailed description: A prospective, randomized-single blinded study included 60 female patients with CNLBP aged 18-60 years. Patients were randomized into 2 groups. The first group (n=30) performed pilates 3 days/week for 8 weeks. Sessions lasted about one hour and supervised by a pilates trainer. The second group (n=30) was given home exercise program 3 times/week for 8 weeks, each session lasting one hour. The evaluations were made both at the beginning and end of the treatment. Evaluation parameters included VAS (visual analogue scale), Oswestry Disability Index, Qubec Disability Scale, Short Form-36 (SF-36), Beck Depression Questionnaire, sit and reach test, Modified Schöber test, sit up test. Multifidus and abdominal muscle thickness were measured by Ultrasonographic Imaging.

Eligibility criteria: Inclusion Criteria:

* chronic non-specific low back pain for \>3 months,
* visual analog scale (VAS) score of 3-6
* female patients aged 18-60 years,
* body mass index (BMI) within normal limits (18.5-24.9 kg/m²)
* ability to continue the program.

Exclusion Criteria:

* Malignancies,
* infections
* inflammatory diseases
* severe osteoporosis,
* arthritis
* metabolic bone diseases
* pregnancy
* cardiovascular diseases that limit effort capacity
* other musculoskeletal conditions that may impede attaining positions required in exercises
* a history of spinal surgery
* cognitive impairment.

Primary outcomes:
measure: VISUAL ANALOGUE SCALE (VAS) for pain
timeFrame: 6 months
measure: The Oswestry Disability Index
timeFrame: 6 months
measure: The Quebec Back Pain Disability Scale
timeFrame: 6 months
measure: Short Form-36
timeFrame: 6 months
measure: Beck Depression Questionnaire
timeFrame: 6 months
measure: Sit and reach test
timeFrame: 6 months
measure: Modified Schöber and sit up tests
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haydarpaşa Numune Education and Research Hospital
Study officials:
References: