Tensiomyography of Gastrocnemius in Lumbar Radiculopathy

NCT06767280 | Recruiting

• 1 other identifier: (No: P.T.REC/012/005417)
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-sectional study aims to evaluate the neuromuscular characteristics of the gastrocnemius muscles in individuals with chronic lumbar radiculopathy using tensiomyography (TMG). By analyzing parameters such as muscle contraction time, displacement, and relaxation time, the study seeks to understand potential alterations in muscle properties that may contribute to functional limitations in this patient population. Findings from this research may provide valuable insights into the role of gastrocnemius muscles in neuromuscular dysfunction and inform tailored rehabilitation strategies.

Conditions

Tensiomyography; Gastrocnemius Muscle Assessment; Chronic Lumbar Radiculopathy

Keywords

Chronic Lumbar Radiculopathy; Tensiomyography (TMG); Gastrocnemius Muscles; Neuromuscular Function; Muscle Assessment; Electrophysiology

Outcome Measures

Primary Outcomes (1)

• Comparison of Muscle Contraction Time (Tc) Between Right and Left Gastrocnemius Muscles in Patients with Chronic Lumbar Radiculopathy

  This outcome measures the difference in muscle contraction time (Tc) between the right and left gastrocnemius muscles in patients diagnosed with chronic lumbar radiculopathy. Muscle contraction time is assessed using tensiomyography (TMG)

  At baseline (single session)" This fits well if you're measuring contraction times of the gastrocnemius muscles in one session.

Study Arms (1)

Right Leg TMG measurements for the right leg. Left Leg TMG measurements for the left leg.

Right Leg Neuromuscular characteristics of the right leg measured using TMG in patients with chronic lumbar radiculopathy. Left Leg Neuromuscular characteristics of the left leg measured using TMG in patients with chronic lumbar radiculopathy.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients diagnosed with chronic lumbar radiculopathy, experiencing persistent lower back pain and/or radiating leg pain. Participants are selected from outpatient clinics and must meet specific inclusion criteria, such as the absence of recent lower limb injuries or surgeries.

You may qualify if:

• Adults aged 18-55 years.
• Clinical diagnosis of chronic lumbar radiculopathy confirmed by MRI and clinical examination.
• Presence of symptoms for more than 12 weeks.
• One limb is affected by the condition, while the other limb is unaffected and will serve as the control.

You may not qualify if:

• ● Acute lumbar radiculopathy (symptoms less than 12 weeks).
• History of lower limb surgery or severe musculoskeletal disorders affecting the plantar flexor muscles.
• Neurological disorders other than lumbar radiculopathy (e.g., peripheral neuropathy, multiple sclerosis).
• Severe comorbid conditions that might interfere with the study (e.g., uncontrolled diabetes, severe cardiovascular disease).
• Pregnant or breastfeeding women.
• Participation in another clinical trial within the last 30 days.
• Use of medications that could affect muscle function (e.g., corticosteroids, muscle relaxants).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cleopatra October Hospital

Sixth of October, Giza Governorate, 12566, Egypt

RECRUITING

Related Publications (2)

• Tous-Fajardo J, Moras G, Rodriguez-Jimenez S, Usach R, Doutres DM, Maffiuletti NA. Inter-rater reliability of muscle contractile property measurements using non-invasive tensiomyography. J Electromyogr Kinesiol. 2010 Aug;20(4):761-6. doi: 10.1016/j.jelekin.2010.02.008. Epub 2010 Mar 16.

  PMID: 20236839 BACKGROUND

• Schmid AB, Fundaun J, Tampin B. Entrapment neuropathies: a contemporary approach to pathophysiology, clinical assessment, and management. Pain Rep. 2020 Jul 22;5(4):e829. doi: 10.1097/PR9.0000000000000829. eCollection 2020 Jul-Aug.

  PMID: 32766466 BACKGROUND

Central Study Contacts

Ahmed Mostafa Nassef, DPT

CONTACT

+201093553771; ahmed4nassef@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student, Faculty of Physiotherapy, Cairo University

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 9, 2025
• Study Start: November 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

EG (1)