NCT07710924

Brief Summary

Sciatica is characterized by radiating pain, functional limitations, reduced flexibility, disturbed sleep, and impaired quality of life. Extracorporeal Shockwave Therapy (ESWT) and Therapeutic Ultrasound are commonly used physiotherapy modalities for pain relief and tissue healing; however, evidence directly comparing their effectiveness remains limited. This randomized controlled trial compares the effects of Shockwave Therapy and Ultrasound Therapy, each combined with conventional physiotherapy, on pain intensity, hamstring range of motion, sleep quality, and quality of life in patients with chronic sciatica.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 30, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

July 14, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

SciaticaChronic SciaticaLumbar RadiculopathyShockwave TherapyExtracorporeal Shockwave Therapy

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity

    Numeric Pain Rating Scale (0-10). Higher scores indicate greater pain.

    Baseline, Week 4, Week 8

  • Hamstring Range of Motion

    Hip flexion measured with a universal goniometer during the Straight Leg Raise test.

    Baseline, Week 4, Week 8

Secondary Outcomes (1)

  • Sleep Quality

    Baseline, Week 4, Week 8

Study Arms (2)

Shockwave Therapy + Conventional Physiotherapy

EXPERIMENTAL

Participants will receive radial extracorporeal shockwave therapy in addition to standardized conventional physiotherapy four times per week for eight weeks.

Device: Extracorporeal Shockwave TherapyOther: Conventional Physiotherapy

Ultrasound Therapy + Conventional Physiotherapy

ACTIVE COMPARATOR

Participants will receive therapeutic ultrasound in addition to standardized conventional physiotherapy four times per week for eight weeks.

Device: Therapeutic UltrasoundOther: Conventional Physiotherapy

Interventions

Conventional physiotherapy will include moist heat therapy, myofascial release, stretching exercises, and strengthening exercises administered during every treatment session.

Shockwave Therapy + Conventional PhysiotherapyUltrasound Therapy + Conventional Physiotherapy

Radial extracorporeal shockwave therapy will be applied to the sciatic nerve origin and piriformis region using standardized treatment parameters for approximately 10 minutes during each treatment session.

Also known as: ESWT, Radial Shockwave Therapy
Shockwave Therapy + Conventional Physiotherapy

Therapeutic ultrasound will be applied to the gluteal and lumbar regions using standardized frequency and intensity parameters for approximately 10 minutes during each treatment session.

Also known as: Ultrasound Therapy, Ultrasound
Ultrasound Therapy + Conventional Physiotherapy

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 20-45 years.
  • Clinically diagnosed chronic sciatica.
  • Radiating pain below the knee.
  • Positive Straight Leg Raise test (30°-70°).
  • Pain intensity ≥4/10 on the Numeric Pain Rating Scale.
  • Symptoms persisting for at least 3 months.
  • Presence of tingling, numbness, lumbar radiculopathy, or piriformis syndrome.

You may not qualify if:

  • Lumbar disc herniation.
  • Progressive neurological disorders.
  • Ankylosing spondylitis.
  • Paget disease.
  • Tuberculosis.
  • Malignancy.
  • Rheumatoid arthritis or other inflammatory disorders.
  • Previous spinal surgery or fracture.
  • Fever, unexplained weight loss, or systemic illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ULTH

Lahore, Pakistan

Location

MeSH Terms

Conditions

SciaticaRadiculopathy

Interventions

Extracorporeal Shockwave TherapyUltrasonic TherapyUltrasonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will remain blinded to treatment allocation throughout the study. Due to the nature of the interventions, participants and treating physiotherapists cannot be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either Shockwave Therapy plus Conventional Physiotherapy or Ultrasound Therapy plus Conventional Physiotherapy. Both groups will receive the same conventional physiotherapy program, while the experimental intervention will differ according to treatment allocation. Outcome assessments will be conducted at baseline, Week 4, and Week 8 by a blinded assessor.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Physical Therapy Student

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start

June 30, 2025

Primary Completion

March 10, 2026

Study Completion

April 12, 2026

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because this study was conducted as an academic research project. The informed consent obtained from participants did not include provisions for public data sharing, and the dataset contains sensitive personal health information. Data will be stored securely and used only for academic and research purposes in accordance with institutional ethics approval.

Locations