- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06827574
Comparative Effects of Sciatic Nerve Flossing and Active Release Technique in Cyclists With Sciatica
February 10, 2025 updated by: Riphah International University
Comparative Effects of Sciatic Nerve Flossing and Active Release Technique on Pain, Flexibility and Functionality in Lower Limbs Among Cyclists With Sciatica
Thus the aim of my study is to determine the comparative effects of sciatic nerve flossing and active release technique on pain, flexibility, and functionality in lower limbs of cyclists with sciatica.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
This study investigates the comparative effects of Sciatic Nerve Flossing and Active Release Technique on pain, flexibility, and functionality in cyclists with sciatica.
To compare the efficacy of Sciatic Nerve Flossing and Active Release Technique in reducing pain and improving functional performance in cyclists diagnosed with sciatica over a six-week period.
A randomized clinical trial was conducted with 32 participants, aged 18 to 35, diagnosed with sciatica persisting for more than six weeks.
Participants were randomly assigned to two groups: Group A received Sciatic Nerve Flossing, while Group B underwent Active Release Technique.
Pain levels were measured using the Numeric Pain Rating Scale (NPRS), functional performance was assessed using the Lower Extremity Functional Score (LEFS), and flexibility was evaluated via the Sit and Reach Test.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Lahore, Punjab, Pakistan
- University of Lahore
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria
- Age between 18 to 30 years (16)
- Only male participants were included (15)
- Participates with Positive Passive Straight Leg Raise (PSLR) Test (13)
- Athletes with positive slump test (15)
- Symptoms more than 6 weeks (16)
Exclusion Criteria:
- Lower limb fracture(13)
- Musculoskeletal problems (radiculopathy, myopathy) (13, 14)
- Sciatica along with vascular disorders and diabetic neuropathy, sciatica due to tumor and fractures (15)
- Inflammatory arthritis (16)
- Previous surgical interventions on the lower limbs or spine (15)
- Neurological conditions affecting lower limb function (e.g., multiple sclerosis, spinal cord injuries) (13, 14)
- Patients currently undergoing physical therapy or other interventions for sciatica (15)
- Individuals with contraindications to physical activity or exercise due to health conditions (13, 14)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sciatic nerve flossing technique
Group A 16 subjects were treated with Sciatic Nerve Flossing Technique.
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Group A 16 subjects were treated with Sciatic Nerve Flossing Technique.
Subjects were in sitting position.
Nerve Flossing Technique was performed actively with the participant sitting on a chair.
The participant was flex the knee of the target lower extremity backwards beside the chair, as far back as possible and flex the neck at the same time, holding both the flexed knee and neck in this position for 10 seconds.
The participant in turn will extend the neck and the knee of the target lower extremity, abduct and then flex the hip until pain is felt and do not push beyond that point.
This extended position was maintained for 10 seconds.
The above procedure of Nerve Flossing Technique was repeated for 15 times, 3 sets with an interval of 5 minutes between each set.
As the nerve becomes less sensitive, the participant can increase the stretching effect by dorsiflexion the ankle and extending the toes of the foot upward towards the shin.
|
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Active Comparator: Active Release Technique
Group B 16 subjects were treated with Active Release Technique
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Group B 16 subjects were treated with Active Release Technique.
Subjects were in prone position.
ART was performed actively by the participant lying on a bed.
The participant was dorsiflex the foot of the target lower extremity, holding the dorsiflexion foot in this position for 10 seconds.
The participant in turn was plantar-flexed the foot of the target lower extremity.
This dorsiflexion position was maintained for 10 seconds.
The above procedure of Active Release Technique was repeated for 15 times, 3 sets with an interval of 5 minutes between each set.
As the muscles becomes more flexible, the participant can increase the flexibility effect by plantar flexing the foot.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NPRS
Time Frame: 6 Weeks
|
The Numeric Aggravation Rating Scale (NPRS) is normally used to survey torment.
Change in the NPRS across time can be deciphered with responsiveness lists.
Patient level of pain will be assessed using this scale.
This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain(48).
High test-retest reliability is indicated by an ICC > 0.70; Cronbach's alpha > 0.70 suggests great internal consistency.
The construct validity of the NPRS examines how well the scores correspond to theoretical pain components, while the criterion validity compares results to established pain measures.(49).
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6 Weeks
|
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Sit and Reach Test
Time Frame: 6 weeks
|
Sit-and-arrive at tests are generally utilized as estimation apparatuses for assessing hamstring and lower back adaptability.
The old style sits and arrive at test (SRT), initially planned by Wells and Dillon (1952) is frequently included as a feature of game related actual wellness test batteries (American Union for Wellbeing Actual Instruction Entertainment and Dance (AAHPERD), 1986, Gathering of Europe Council for the Improvement of Game, 1993) to assess hamstring muscle adaptability.
The SRT and TT test have a similar testing strategy (maximal trunk flexion with knee straight and lower leg in 90° of dorsiflexion) with the main contrast being the trying position, sitting and standing, separately(50).
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6 weeks
|
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Lower Extremity Funtional Score
Time Frame: 6 weeks
|
The reasonable structure that directed the improvement of the LEFS incorporated that the scale be founded on the World Wellbeing Association's model of incapacity and impairment, be effective to manage, score, and record in the clinical record as for patient and clinician time, be pertinent to a wide assortment of patients with lower-limit muscular circumstances, incorporating patients with a scope of handicap levels, conditions, illnesses, medicines, and ages, be material for reporting capability on a singular patient premise as well as in gatherings, for example, for clinical results evaluation and clinical examination designs, be created utilizing an efficient course of thing determination and thing scaling, yield solid estimations (have inner consistency and test-retest dependability), and yield substantial estimations (at a solitary moment and delicate to legitimate change)(51)(52).
While ICC > 0.70 indicates good reliability for LEFS, Cronbach's alpha > 0.70 ensures internal con
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Farwa Imtiaz Ahmad, DPT, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Michener LA, Snyder AR, Leggin BG. Responsiveness of the numeric pain rating scale in patients with shoulder pain and the effect of surgical status. J Sport Rehabil. 2011 Feb;20(1):115-28. doi: 10.1123/jsr.20.1.115.
- Mehta SP, Fulton A, Quach C, Thistle M, Toledo C, Evans NA. Measurement Properties of the Lower Extremity Functional Scale: A Systematic Review. J Orthop Sports Phys Ther. 2016 Mar;46(3):200-16. doi: 10.2519/jospt.2016.6165. Epub 2016 Jan 26.
- Zhang YH, Hu HY, Xiong YC, Peng C, Hu L, Kong YZ, Wang YL, Guo JB, Bi S, Li TS, Ao LJ, Wang CH, Bai YL, Fang L, Ma C, Liao LR, Liu H, Zhu Y, Zhang ZJ, Liu CL, Fang GE, Wang XQ. Exercise for Neuropathic Pain: A Systematic Review and Expert Consensus. Front Med (Lausanne). 2021 Nov 24;8:756940. doi: 10.3389/fmed.2021.756940. eCollection 2021.
- Chiaramonte R, Pavone P, Vecchio M. Diagnosis, Rehabilitation and Preventive Strategies for Pudendal Neuropathy in Cyclists, A Systematic Review. J Funct Morphol Kinesiol. 2021 May 10;6(2):42. doi: 10.3390/jfmk6020042.
- Battista S, Sansone LG, Testa M. Prevalence, Characteristics, Association Factors of and Management Strategies for Low Back Pain Among Italian Amateur Cyclists: an Observational Cross-Sectional Study. Sports Med Open. 2021 Oct 28;7(1):78. doi: 10.1186/s40798-021-00370-2.
- Chang TT, Li Z, Zhu YC, Wang XQ, Zhang ZJ. Effects of Self-Myofascial Release Using a Foam Roller on the Stiffness of the Gastrocnemius-Achilles Tendon Complex and Ankle Dorsiflexion Range of Motion. Front Physiol. 2021 Sep 17;12:718827. doi: 10.3389/fphys.2021.718827. eCollection 2021.
- Dingemans SA, Kleipool SC, Mulders MAM, Winkelhagen J, Schep NWL, Goslings JC, Schepers T. Normative data for the lower extremity functional scale (LEFS). Acta Orthop. 2017 Aug;88(4):422-426. doi: 10.1080/17453674.2017.1309886. Epub 2017 Mar 28.
- Danazumi MS, Nuhu JM, Ibrahim SU, Falke MA, Rufai SA, Abdu UG, Adamu IA, Usman MH, Daniel Frederic A, Yakasai AM. Effects of spinal manipulation or mobilization as an adjunct to neurodynamic mobilization for lumbar disc herniation with radiculopathy: a randomized clinical trial. J Man Manip Ther. 2023 Dec;31(6):408-420. doi: 10.1080/10669817.2023.2192975. Epub 2023 Mar 22.
- Ashbrook J, Rogdakis N, Callaghan MJ, Yeowell G, Goodwin PC. The therapeutic management of back pain with and without sciatica in the emergency department: a systematic review. Physiotherapy. 2020 Dec;109:13-32. doi: 10.1016/j.physio.2020.07.005. Epub 2020 Jul 23.
- Albert HB, Manniche C. The efficacy of systematic active conservative treatment for patients with severe sciatica: a single-blind, randomized, clinical, controlled trial. Spine (Phila Pa 1976). 2012 Apr 1;37(7):531-42. doi: 10.1097/BRS.0b013e31821ace7f.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2024
Primary Completion (Estimated)
February 10, 2025
Study Completion (Estimated)
February 15, 2025
Study Registration Dates
First Submitted
February 10, 2025
First Submitted That Met QC Criteria
February 10, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 10, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/24/0404
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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