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Effects of Pilates Exercises and Neural Dynamic Mobilization in Sciatica Patients

Primary Purpose

Sciatica

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pilates Exercises
Neural dynamic mobilization
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sciatica focused on measuring Neurodynamic Mobilization

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Service Hospital Lahore
  • Service Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Pilates Exercises

Neural dynamic mobilization

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Back pain functional questionnaire to access pain
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
Sit and reach test for flexibility
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.
SF-36 questionnaire to access quality of life
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.

Secondary Outcome Measures

Full Information

First Posted
March 31, 2023
Last Updated
July 23, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05959317
Brief Title
Effects of Pilates Exercises and Neural Dynamic Mobilization in Sciatica Patients
Official Title
Effect of 6-weeks Pilates Exercise Versus Neural Dynamic Mobilization on Pain, Flexibility and Quantity of Life in Patients With Sciatica.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2023 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica
Keywords
Neurodynamic Mobilization

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pilates Exercises
Arm Type
Other
Arm Description
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.
Arm Title
Neural dynamic mobilization
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pilates Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Neural dynamic mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Back pain functional questionnaire to access pain
Description
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
Time Frame
Changes from baseline Back Pain Function Scale (BPFS) at 1.5 months
Title
Sit and reach test for flexibility
Description
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.
Time Frame
Changes from baseline Sit and reach test at 1.5 months
Title
SF-36 questionnaire to access quality of life
Description
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.
Time Frame
Changes from baseline Short Form 36 Health Survey Questionnaire (SF-36) at 1.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Iqbal, DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service Hospital Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Facility Name
Service Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
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Effects of Pilates Exercises and Neural Dynamic Mobilization in Sciatica Patients

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