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TensiomyographyTMGGLRNCT06767280

Tensiomyography of Gastrocnemius in Lumbar Radiculopathy

An observational study of Tensiomyography and Gastrocnemius Muscle Assessment, run by Cairo University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This cross-sectional study aims to evaluate the neuromuscular characteristics of the gastrocnemius muscles in individuals with chronic lumbar radiculopathy using tensiomyography (TMG). Read more about this study

Who is it for?
Ages 18 to 55 years
How many people
38 participants
Where
1 siteEgypt
Study dates
1 Nov 2024to Jul 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • ● 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ahmed Mostafa Nassef, DPT contact

+201093553771

ahmed4nassef@gmail.com

Egypt1 site, 1 recruiting
  • Cleopatra October Hospital

    Sixth of October, Giza Governorate, 12566

    Hayam Mohamed orthopedic HOD, +201155748211, hayammohamed617@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Tensiomyography Evaluation of Gastrocnemius Muscles In Individuals With Chronic Lumbar Radiculopathy

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.

Read the detailed description

Lumbar radiculopathy is a condition characterized by the compression or irritation of one or more nerve roots in the lumbar spine, often resulting in pain, weakness, numbness, or difficulty controlling specific muscles. The primary causes of lumbar radiculopathy include herniated discs, spinal stenosis, and degenerative disc disease. These conditions lead to nerve root compression, resulting in radiating pain down the leg, commonly referred to as sciatica.

The impact of lumbar radiculopathy extends beyond pain, affecting muscle function and neuromuscular control. The involvement of nerve roots such as L4, L5, and S1 can particularly affect the muscles in the lower extremities, including the plantar flexor muscles, which are crucial for movements like walking, running, and maintaining balance. These muscles, namely the gastrocnemius and soleus, play a pivotal role in plantar flexion, an essential motion for locomotion.

In individuals with lumbar radiculopathy, the neural input to these muscles can be compromised, leading to muscle weakness, altered reflexes, and changes in muscle activation patterns. Studies have shown that patients with lumbar radiculopathy often exhibit decreased muscle strength and endurance in the affected lower extremity. These neuromuscular deficits can contribute to impaired gait mechanics and an increased risk of falls, significantly affecting the quality of life.

Tensiomyography (TMG) is a non-invasive diagnostic tool used to assess the contractile properties of skeletal muscles. TMG measures the muscle belly's displacement in response to a standardized electrical stimulus, providing valuable information about muscle function. Key parameters measured by TMG include contraction time (Tc), delay time (Td), sustain time (Ts), relaxation time (Tr) and Displacement (Dm) reflecting the muscle's response speed, duration of contraction, and recovery.

TMG has gained popularity in both clinical and sports settings due to its ability to detect muscle imbalances, monitor rehabilitation progress, and guide training programs. Its non-invasive nature and the detailed information it provides make it an ideal tool for assessing muscle health and function in various populations, including those with neuromuscular disorders.

The intersection of lumbar radiculopathy, plantar flexor muscle function, and TMG presents a compelling area of study. The nerve root compression in lumbar radiculopathy can lead to altered neuromuscular control of the plantar flexor muscles, resulting in changes in muscle contractile properties. TMG can effectively capture these changes, providing insights into the extent of neuromuscular impairment and guiding targeted rehabilitation strategies.

Studies utilizing TMG have demonstrated significant differences in the contractile properties of muscles in individuals with lumbar radiculopathy compared to healthy controls. For instance, longer contraction and relaxation times in the plantar flexor muscles indicate a delay in muscle response and recovery, which could be attributed to compromised neural input from the affected lumbar nerve roots. These findings underscore the importance of neuromuscular assessments in patients with lumbar radiculopathy.

By identifying specific deficits in muscle function, TMG can help clinicians design individualized rehabilitation programs aimed at restoring normal muscle activity and improving overall functional outcomes. Rehabilitation strategies may include strength training, neuromuscular re-education, and proprioceptive exercises tailored to address the specific impairments identified through TMG assessments.

Recent research has focused on the application of TMG in various clinical settings, including the assessment of neuromuscular disorders like lumbar radiculopathy. These studies provide evidence supporting the use of TMG as a reliable tool for evaluating muscle function and guiding rehabilitation.

The integration of TMG in evaluating the plantar flexor muscles in individuals with chronic lumbar radiculopathy provides a nuanced understanding of the neuromuscular impairments associated with this condition. By leveraging the detailed insights from TMG assessments, clinicians can develop targeted rehabilitation strategies to improve muscle function, enhance mobility, and ultimately, the quality of life for patients suffering from lumbar radiculopathy. The ongoing research and clinical applications of TMG continue to expand its utility, offering promising avenues for advancing neuromuscular diagnostics and rehabilitation

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06767280
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2025
  2. Study start1 Nov 2024
  3. Primary completionMar 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Cross-sectional
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06767280
Sponsor's protocol ID
(No: P.T.REC/012/005417)
Acronym
TMGGLR
Status last verified
Jan 2025
First submitted
31 Dec 2024
Last updated
9 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20236839
  • 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.

    PubMed 32766466

Questions about this trial

What is this clinical trial studying?

An observational study of Tensiomyography and Gastrocnemius Muscle Assessment, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ahmed Mostafa Nassef, DPT (+201093553771, ahmed4nassef@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Muscle Contraction Time (Tc) Between Right and Left Gastrocnemius Muscles in Patients with Chronic Lumbar Radiculopathy (time frame: At baseline (single session)" This fits well if you're measuring contraction times of the gastrocnemius muscles in one session.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06767280, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.

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