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Effects of Pilates Exercises and Neural Dynamic Mobilization in Sciatica Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05959317
Recruitment Status : Completed
First Posted : July 25, 2023
Last Update Posted : December 27, 2023
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Study Description
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Brief Summary:
The main purpose of the study is to find the effects of Pilates exercises and neural mobilization techniques on pain, flexibility and quality of life in sciatica patients. It will be a randomized controlled trial in which participants selected through non probability convenience sampling, to evaluate the effect of 6-week Pilates exercises versus neural dynamic mobilization techniques on pain, flexibility and quality of life in sciatica patients. Patients aged range from 18 to 65 years. The data will be collected from Service Hospital Lahore. Patients will have diagnosed with sciatica low back pain radiating down hip to knee, numbness, paresthesia and with positive SLR will include in this study whereas patients with considerable musculoskeletal deformity, previous hip, knee and ankle surgery and foot ulceration will be excluded from study .The participants will be randomly allocated to one of the two groups. Group A will perform Pilates mats exercises 30 minutes, two times a week and the Group B will perform neural dynamic mobilization for 15 minutes, two times a week, for 6-weeks respectively. Pain will be assessed by using BPFS, flexibility with Canadian sit to reach test and QOL with SF-36 questionnaire. SPSS software will be used for data entry and analysis.

Condition or disease Intervention/treatment Phase
Sciatica Other: Pilates Exercises Other: Neural dynamic mobilization Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Effect of 6-weeks Pilates Exercise Versus Neural Dynamic Mobilization on Pain, Flexibility and Quantity of Life in Patients With Sciatica.
Actual Study Start Date : March 5, 2023
Actual Primary Completion Date : July 15, 2023
Actual Study Completion Date : July 30, 2023

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Arms and Interventions
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Arm Intervention/treatment
Pilates Exercises
Pilates exercises will be perform for 15-30 minutes for one session 3 days a week for 6-weeks than after 6 week reassess the QOL, pain and flexibility.
 Other: Pilates Exercises
Pilates exercises will be perform for 15-30 minutes for one session 3 days a week for 6-weeks than after 6 week reassess the QOL, pain and flexibility.
Neural dynamic mobilization
Neural dynamic mobilization will be perform for 15-30 minutes for one session 3 days a week for 6-weeks after 6 weeks reassess the QOL, pain and flexibility.
 Other: Neural dynamic mobilization
Neural dynamic mobilization will be perform for 15-30 minutes for one session 3 days a week for 6-weeks after 6 weeks reassess the QOL, pain and flexibility.


Outcome Measures
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Primary Outcome Measures :
  1. Back pain functional questionnaire to access pain [ Time Frame: Changes from baseline Back Pain Function Scale (BPFS) at 1.5 months ]
    The Back Pain Function Scale (BPFS) of Stratford et al Overview: Stratford et al developed the Back Pain Function Scale (BPFS) to evaluation functional ability in patients with back pain. The authors are from McMaster University Appalachian Physical Therapy (Georgia) and Virginia Commonwealth University. Interpretation: • minimum score: 0 • maximum score: 60 • maximum adjusted score: 1 (100%) • The higher the score the greater the patient's functional ability. Total Score (Adjusted) Interpretation: 0 (0%) unable to perform any activity 60 (100%) no difficulty in any activity Performance

  2. Sit and reach test for flexibility [ Time Frame: Changes from baseline Sit and reach test at 1.5 months ]
    Sit and Reach Test The objective of this test is to monitor the development of the athlete's lower back and hamstring flexibility. Required resources to undertake this test you will require: 'Sit & reach' table or a bench with a ruler for Assistant. This test is suitable for active individuals but not for those where the test would be contraindicated.

  3. SF-36 questionnaire to access quality of life [ Time Frame: Changes from baseline Short Form 36 Health Survey Questionnaire (SF-36) at 1.5 months ]

    The Short Form 36 Health Survey Questionnaire (SF-36) is used to indicate the health status of particular populations, to help with service planning and to measure the impact of clinical and social interventions.

    To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • o Participants age ranged from 18 to 65 years old

    • Both genders.
    • History of nonspecific low back
    • lower extremity symptoms such as tingling, dull aches or burning sensation.

Exclusion Criteria:

  • o Significant musculoskeletal deformity such as fracture, amputation.

    • Prior history of knee or back surgery
    • Lower extremity arthritis that limits standing and any inflammatory disease
    • History of cardiovascular issues such as angina, MI
    • Symptomatic postural hypotension
    • Foot ulceration.
    • Skin problems such as rashes etc.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05959317


Locations
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Pakistan
Service Hospital Lahore
Lahore, Punjab, Pakistan, 54000
Service Hospital
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Maria Iqbal, DPT Riphah International University
More Information
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Publications:
Vartak HS, Rajapurkar R, Palekar T, Saini S, Khisty A. A comparative study between neural mobilisation techniques versus nerve flossing technique in patients with acute sciatica. International Journal of Basic and Applied Research. 2019;9(3):909-22.

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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT05959317    
Other Study ID Numbers: RiphahIU Maria Iqbal
First Posted: July 25, 2023    Key Record Dates
Last Update Posted: December 27, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Neurodynamic Mobilization
Additional relevant MeSH terms:
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Sciatica
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Neuralgia
Pain
Neurologic Manifestations