NCT07089472

Brief Summary

This study is designed to compare the effectiveness of two physiotherapy techniques-Dry Needling and the Cyriax Technique-in people suffering from chronic low back pain (CLBP) that radiates to the outer thigh, a condition commonly known as meralgia paresthetica. Meralgia paresthetica occurs when a nerve called the lateral femoral cutaneous nerve (LFCN) gets compressed, leading to pain, numbness, tingling, or burning sensations in the front or side of the thigh. Many patients also experience difficulty in performing daily activities because of these symptoms. Dry Needling is a modern treatment where fine, sterile needles are inserted into specific muscles to relieve tension and improve nerve function. It is believed to release natural pain-relieving chemicals and reduce inflammation. On the other hand, the Cyriax Technique is a manual therapy approach involving deep friction massage and gentle mobilizations targeted at the affected nerve area to reduce pressure and pain. In this study, 80 participants between the ages of 30 and 50 years, who have had low back pain for more than three months and symptoms of nerve entrapment in the thigh, will be randomly divided into two groups. One group will receive Dry Needling therapy, and the other will receive Cyriax treatment. Both groups will also receive standard physiotherapy, including heat therapy, muscle stimulation, and stretching exercises. Treatment will continue for 8 weeks (2 sessions per week). The aim is to evaluate and compare changes in pain, tingling/numbness (paraesthesia), and daily life functioning using recognized clinical tools such as the Visual Analogue Scale (VAS), Neuropathic Pain Symptom Inventory (NPSI), and the Roland-Morris Disability Questionnaire (RMDQ). Data will be collected at the beginning, and then again after 2, 4, and 8 weeks. This research will help determine which therapy-Dry Needling or Cyriax-is more effective in treating patients with this type of nerve-related back and thigh pain. The findings may guide physiotherapists and healthcare providers in choosing the most suitable treatment for managing meralgia paresthetica in chronic low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

July 20, 2025

Last Update Submit

July 20, 2025

Conditions

Keywords

Chronic low back painCyriax techniqueDry needlingFunctional disabilityMeralgia parestheticaNeuropathic painParaesthesiaPhysiotherapy

Outcome Measures

Primary Outcomes (3)

  • Change in Pain Intensity Measured by Visual Analogue Scale (VAS)

    Pain intensity will be assessed using the Visual Analogue Scale, a 10-cm line ranging from "no pain" to "worst possible pain." Participants will mark their pain level at each assessment point.

    Baseline, 2nd week, 4th week, and 8th week

  • Change in Paraesthesia Measured by Neuropathic Pain Symptom Inventory (NPSI)

    Paraesthesia symptoms including tingling, burning, and numbness will be assessed using the NPSI, a self-report tool evaluating intensity and frequency of neuropathic pain symptoms.

    Baseline, 2nd week, 4th week, and 8th week

  • Change in Functional Disability Measured by Roland-Morris Disability Questionnaire (RMDQ)

    Functional disability will be assessed using the RMDQ, a 24-item self-report questionnaire measuring the impact of low back pain on daily activities. Higher scores indicate greater disability.

    Baseline, 2nd week, 4th week, and 8th week

Study Arms (2)

Dry Needling Group

EXPERIMENTAL

Participants in this group will receive dry needling therapy targeting muscles along the route of the lateral femoral cutaneous nerve (LFCN), including the piriformis, iliacus, tensor fascia latae, vastus lateralis, and sartorius. Each session will involve needle insertion (90 sec-2 mins) with retention for 15 minutes. Sessions will be conducted twice a week for 8 weeks (total 16 sessions). Standard physiotherapy (hot pack, EMS, stretching) will be provided alongside.

Behavioral: Dry Needling Therapy

Cyriax Technique Group

ACTIVE COMPARATOR

Participants in this group will receive the Cyriax technique (deep transverse friction massage and nerve mobilization) applied along the LFCN pathway near the anterior superior iliac spine (ASIS). Each session will involve 3-5 repetitions of mobilization, with 10-15 second holds. Sessions will be conducted twice a week for 8 weeks (total 16 sessions). Standard physiotherapy (hot pack, EMS, stretching) will be provided alongside.

Behavioral: Cyriax Technique

Interventions

Dry needling will be applied along the lateral femoral cutaneous nerve (LFCN) pathway, targeting muscles such as piriformis, iliacus, tensor fascia latae, vastus lateralis, and sartorius. Sterile solid filiform needles (0.25x30mm and 0.30x50mm) will be inserted for 90 seconds to 2 minutes using a cone technique and retained in situ for 15 minutes. Sessions will occur twice weekly for 8 weeks, with standard physiotherapy (hot pack, EMS, and guided stretches) administered alongside.

Dry Needling Group

The Cyriax technique involves deep friction massage and mobilization of the lateral femoral cutaneous nerve (LFCN) near the anterior superior iliac spine (ASIS). Using the "pinch and roll" and deep pressure technique, therapists will apply sustained pressure along the nerve path in 3-5 repetitions per session, holding each for 10-15 seconds. Sessions will occur twice weekly for 8 weeks, alongside standard physiotherapy modalities and exercises.

Cyriax Technique Group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with chronic low back pain (time to onset ≥ 3 months) (Erbay, 2002).
  • Roland Morris Disability Questionnaire score ≥ 4 (Lara-Palomo et al., 2022).
  • CLBP radiating to Anterolateral thigh with symptoms of numbness tingling (de Ruiter et al., 2023).

You may not qualify if:

  • Patients with sensory and/or coagulation disorders (Lara-Palomo et al., 2022).
  • A history of spinal surgery, heart complications, concurrent severe central or peripheral nervous system disease (de Ruiter et al., 2023).
  • Epilepsy, needle phobia, serious pathologies that can be the main cause of chronic low back pain other than meralgia parasthetica (Lara-Palomo et al., 2022).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, 54590, Pakistan

Location

Related Publications (1)

  • de Ruiter GCW, Oosterhuis JWA, Vissers TFH, Kloet A. Unusual causes for meralgia paresthetica: systematic review of the literature and single center experience. Neurosurg Rev. 2023 May 6;46(1):107. doi: 10.1007/s10143-023-02023-2.

    PMID: 37148363BACKGROUND

MeSH Terms

Conditions

Femoral NeuropathyNeuralgiaParesthesia

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersSensation Disorders

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
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

July 20, 2025

First Posted

July 28, 2025

Study Start

November 25, 2024

Primary Completion

June 11, 2025

Study Completion

July 19, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations