NCT06827574

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

February 10, 2025

Last Update Submit

February 10, 2025

Conditions

Keywords

Active release techniquecyclistsfunctional performancepain managementsciaticasciatic nerve flossing technique

Outcome Measures

Primary Outcomes (3)

  • NPRS

    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).

    6 Weeks

  • Sit and Reach Test

    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).

    6 weeks

  • Lower Extremity Funtional Score

    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

    6 weeks

Study Arms (2)

Sciatic nerve flossing technique

EXPERIMENTAL

Group A 16 subjects were treated with Sciatic Nerve Flossing Technique.

Other: Sciatic nerve flossing technique

Active Release Technique

ACTIVE COMPARATOR

Group B 16 subjects were treated with Active Release Technique

Other: Active Release Technique

Interventions

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.

Sciatic nerve flossing technique

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.

Active Release Technique

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male participants were included
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore

Lahore, Punjab Province, Pakistan

Location

Related Publications (10)

  • 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.

    PMID: 34068471BACKGROUND
  • 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.

    PMID: 34709475BACKGROUND
  • 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.

    PMID: 34901069BACKGROUND
  • 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.

    PMID: 34603078BACKGROUND
  • 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.

    PMID: 26813750BACKGROUND
  • 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.

    PMID: 28350206BACKGROUND
  • 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.

    PMID: 21411827BACKGROUND
  • 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.

    PMID: 36950742BACKGROUND
  • 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.

    PMID: 32846282BACKGROUND
  • 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.

    PMID: 21494193BACKGROUND

MeSH Terms

Conditions

SciaticaAgnosia

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral Manifestations

Study Officials

  • Farwa Imtiaz Ahmad, DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 14, 2025

Study Start

April 24, 2024

Primary Completion

February 10, 2025

Study Completion

February 15, 2025

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations