Effects of Neuro-dynamic Mobilization Techniques on Upper Limb Functions in Pronator Teres Syndrome

August 13, 2024 updated by: Riphah International University
The study aimed to determine the effects of neuro-dynamic techniques on upper limb motor and sensory functions and to compare the effects of slider versus tensioner neuro-dynamic techniques on upper limb motor and sensory functions in pronator teres syndrome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study aimed to determine the effects of neuro-dynamic techniques on upper limb motor and sensory functions and to compare the effects of slider versus tensioner neuro-dynamic techniques on upper limb motor and sensory functions in pronator teres syndrome.

Pronator teres syndrome is a rare condition and easily overlooked and mistaken for the more prevalent carpal tunnel syndrome. The median nerve may also be squeezed between the heads of the pronator teres muscle in addition to the carpal tunnel. Patients report pain, numbness, or paresthesia over the lateral 3.5-digit area and anterior forearm, which worsens with forced pronation. This condition is most common in the dominant hand or sometimes can be associated with advanced forearm muscle.in our routine clinical practice, The neuro-dynamic techniques is not that common in neurological physical therapy practice so the effects of neuro -dynamics with conventional therapy needs to be evaluated for better outcomes in upper limb functions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Islamabad, Punjab, Pakistan, 46060
        • Al-Nafees hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with pronator teres syndrome
  • At least 6 working hours/ day
  • Positive Tinel's sign at pronator area (Hoffman's sign)
  • Positive Pronator teres syndrome test

Exclusion Criteria:

  • Any previous history of metabolic disease, liver disease/ diabetes
  • History of previous injuries to the cervical spine including radiculopathies and myelopathies as well as spinal stenosis and/or spinal disc herniation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Upper Limb Neurodynamics Group
Upper limb Neuro-dynamics (Slider/Tensioner Technique) along with Task Oriented Training
Other: Upper limb Neuro-dynamics (Slider/ Tensioner Technique)
The experimental group will receive neuro-dynamic mobilization techniques along with task oriented training. Slider versus tensioner technique will be applied according to each patient's need. Session time will be 25-30 minutes. Four series of 10 tensioning movements at a rhythm of ∼6s per cycle and 1 min rest between each series will be performed. After each cycle of 10 repetitions, the position will hold for 10s.
Active Comparator: Upper Limb Conventional Therapy
Stretching, Strengthening exercises along with Task Oriented Training
Other: Conventional Therapy for Upper limb
Conventional treatment will include therapeutic ultrasound for 4 min, TENS for 10 min. Task oriented training will be designed according to patient's functional outcomes. Sessions will be given for 6 days a week, 25-30 minutes per day.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric visual analogue scale (VAS)
Time Frame: 2 weeks
Numeric visual analogue scale (VAS) is a self-reported assessment that consists of a line with severe anchors ranging from "no pain" to "intense pain", which can be vertical or horizontal. Most frequently 10 cm long, this line serves as a continuum of pain severity. High test-retest reliability for the VAS has been recorded (ICC = 0.71-0.99). VAS is regarded as a powerful, therapeutically practical, accurate, and true measure of pain severity.
2 weeks
Upper Extremity Functional Scale (UEFS)
Time Frame: 2 weeks
Upper Extremity Functional Scale (UEFS) is an 8-item, region-specific questionnaire designed to evaluate diseases of the upper extremities caused by work. The UEFS is a valid, reliable, and responsive tool created to assess how patients with a range of diseases are affected by upper extremity disorders in terms of function. UEFS demonstrate good internal consistency (Cronbach alpha > 0.83).
2 weeks
Jamar hand held dynamometer
Time Frame: 2 weeks
Jamar hand held dynamometer is widely used in clinical practice and research as a result of the American Society of Hand Therapists (ASHT) recommendation of it as the gold standard. The ICC for the Jamar dynamometer ranged from .996 to .998 (p< 0.05).
2 weeks
Nottingham sensory assessment Scale
Time Frame: 2 weeks
The Nottingham sensory assessment is a standardized scale for assessing sensory assessment in stroke patients. The NSA consists of 20 items and four subscales. The subscales included proprioception, stereognosis, two-point discrimination and tactile feeling. Each subscales item on tactile location on both sides of the body and bilateral simultaneous contact can be graded on the scale of 0-2. The Cronbach's alpha was used to evaluate internal consistency, values over 0.70 indicate Strong internal consistency.
2 weeks
Wolf Motor Function Test
Time Frame: 2 weeks
Wolf Motor Function Test (WMFT) quantifies upper extremity movement ability through timed single- or multiple-joint motions and functional tasks. The original version consisted of 21 item; the widely used version of the WMFT consists of 17 items Composed of 3 parts: Time, Functional ability &Strength. It Includes 15 function-based tasks and 2 strength based tasks Performance time is referred to as WMFT-TIME. Functional ability is referred to as WMFT-FAS. Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. The WMFT is an instrument with high inter rater reliability, internal consistency, test-retest reliability, and adequate stability.
2 weeks
Range of Motion
Time Frame: 2 weeks
Goniometer is a method for measuring joint range of motion (ROM) that is widely accepted. It uses accurate and reliable measurement tools, especially the universal goniometer. For goniometry, Intraclass Correlation Coefficients (ICC- 3, k) of 0.94 showed excellent intra-ratter reliability.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abrish Habib Abbasi, MS-NMPT, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Umaira Sattar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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