NCT05959317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

March 31, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

Neurodynamic Mobilization

Outcome Measures

Primary Outcomes (3)

  • 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

    Changes from baseline Back Pain Function Scale (BPFS) at 1.5 months

  • 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.

    Changes from baseline Sit and reach test at 1.5 months

  • 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.

    Changes from baseline Short Form 36 Health Survey Questionnaire (SF-36) at 1.5 months

Study Arms (2)

Pilates Exercises

OTHER

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

Neural dynamic mobilization

OTHER

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

Interventions

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.

Pilates Exercises

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.

Neural dynamic mobilization

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Service Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Sciatica

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Maria Iqbal, DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2023

First Posted

July 25, 2023

Study Start

March 5, 2023

Primary Completion

July 15, 2023

Study Completion

July 30, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations