NCT07015606

Brief Summary

to determine the therapeutic effectiveness of sciatic nerve mobilization compared to femoral nerve mobilization along with electrical stimulation in promoting functional recovery and alleviating symptoms in patients with low back pain and to reveal which one is more effective for pain relief and functional improvement in low back pain patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable low-back-pain

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

June 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 28, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

June 3, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

Low Back Pain (LBP)

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale (VAS)

    Pain intensity was further measured using the Visual Analog Scale (VAS), ranging from 0 mm (no pain) to 100 mm (worst imaginable pain). VAS scores were categorized as follows: 0-4 mm indicating no pain, 5-44 mm mild pain, 45-74 mm moderate pain, and 75-100 mm severe pain.21

    8 WEEKS

Secondary Outcomes (3)

  • Oswestry disability index (ODI)

    8 WEEKS

  • Goniometer for range of motion (ROM)

    8 WEEKS

  • EuroQol 5 Dimension Questionnaire (EQ-5D)

    8 WEEKS

Study Arms (2)

Sciatic nerve mobilization with Electrical Muscle Stimulation

OTHER

Each patient will receive therapeutic sessions over 2 weeks (3 sessions per week), with total of 6 sessions. The repetition of mobilization will be 10 times for 2 sets with 2 minutes rest in between the sets. Electrical Muscle Stimulation (EMS) device was applied at a pulse frequency of 100 Hz. Placement of 2 surface electrodes will be used for stimulation over a session period of 15 minutes.

Other: Sciatic nerve mobilization with EMS

Femoral neural mobilization with Electrical Muscle Stimulation

OTHER

Each patient will receive therapeutic sessions over 2 weeks (3 sessions per week), with total of 6 sessions. The repetition of mobilization will be 10 times for 2 sets with 2 minutes rest in between the sets. Electrical Muscle Stimulation (EMS) device was applied at a pulse frequency of 100 Hz. Placement of 2 surface electrodes will be used for stimulation over a session period of 15 minutes.

Other: Femoral neural mobilization with EMS

Interventions

Patients in both groups will receive electrical muscle stimulation. In addition, the group A will receive sciatic neural mobilization and group B will receive femoral neural mobilization. Patients were not allowed to take medication for pain during the study or to receive any other form of treatment outside the study. EMS device was applied at a pulse frequency of 100 Hz. Placement of 2 surface electrodes will be used for stimulation over a session period of 15 minutes. The repetition of mobilization will be 10 times for 2 sets with 2 minutes rest in between the sets. The frequency of Electrical muscle stimulation and the duration of neural mobilization will be increased after every session up to 10 Hz and 3 mints respectively.

Sciatic nerve mobilization with Electrical Muscle Stimulation

Patients in both groups will receive electrical muscle stimulation. In addition, the group A will receive sciatic neural mobilization and group B will receive femoral neural mobilization. Patients were not allowed to take medication for pain during the study or to receive any other form of treatment outside the study. EMS device was applied at a pulse frequency of 100 Hz. Placement of 2 surface electrodes will be used for stimulation over a session period of 15 minutes. The repetition of mobilization will be 10 times for 2 sets with 2 minutes rest in between the sets. The frequency of Electrical muscle stimulation and the duration of neural mobilization will be increased after every session up to 10 Hz and 3 mints respectively.

Femoral neural mobilization with Electrical Muscle Stimulation

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20-50 years
  • Radiating pain pattern
  • Muscular pain pattern
  • Negative sensory and motor neural examination
  • Patients with peripheral nerve sensitization were included if they were adults and had leg pain duration of \< 3 months(8)
  • VAS Score between 4 and 8
  • Positive findings of tests like thigh thrust, Patrick's Faber test, Gaenslen's test, modified Trendelenburg's test and Slump test.

You may not qualify if:

  • Pregnancy
  • Post-partum females
  • Serious spinal pathology
  • Sensory and motor deficient
  • History of back and lower extremity surgery
  • Patients with contraindication to Electrical Stimulation
  • Any serious kind of co-morbidities like malignancy, infections
  • Any kind of disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 11, 2025

Study Start

August 28, 2025

Primary Completion

November 10, 2025

Study Completion

November 29, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06