Pronator Teres SyndromeNCT06009692
Effects of Neuro-dynamic Mobilization Techniques on Upper Limb Functions in Pronator Teres Syndrome
A study testing Upper limb Neuro-dynamics (Slider/ Tensioner Technique) and Conventional Therapy for Upper limb in people with Pronator Teres Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Pronator Teres Syndrome
- What is being tested?
- Upper limb Neuro-dynamics (Slider/ Tensioner Technique) and Conventional Therapy for Upper limb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Aug 2023to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pronator Teres Syndrome
- Being tested
- Upper limb Neuro-dynamics (Slider/ Tensioner Technique), Conventional Therapy for Upper limb
- Keywords
- Upper limb functions, Neurodynamics, Pronator Teres Syndrome, Task Oriented training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper limb Neuro-dynamics (Slider/ Tensioner Technique)Other
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.
Conventional Therapy for Upper limbOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Upper Limb Neurodynamics Group | Experimental | Upper limb Neuro-dynamics (Slider/Tensioner Technique) along with Task Oriented Training Receives: Other: Upper limb Neuro-dynamics (Slider/ Tensioner Technique) |
| Upper Limb Conventional Therapy | Active comparator | Stretching, Strengthening exercises along with Task Oriented Training Receives: Other: Conventional Therapy for Upper limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric visual analogue scale (VAS)
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.
Measured: 2 weeks
Upper Extremity Functional Scale (UEFS)
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).
Measured: 2 weeks
Jamar hand held dynamometer
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).
Measured: 2 weeks
Range of Motion
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.
Measured: 2 weeks
Nottingham sensory assessment Scale
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.
Measured: 2 weeks
Wolf Motor Function Test
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start20 Aug 2023
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pronator Teres SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abrish Habib Abbasi, MS-NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009692
- Sponsor's protocol ID
- Umaira Sattar
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2023
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuro-dynamic Mobilization Techniques on Upper Limb Functions in Pronator Teres Syndrome
- ClinicalTrials.gov ID
- NCT06009692
- Acronym / sponsor ID
- Umaira Sattar
- Conditions
- Pronator Teres Syndrome
- Keywords
- Upper limb functions, Neurodynamics, Pronator Teres Syndrome, Task Oriented training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper Limb Neurodynamics Group | Experimental | Other: Upper limb Neuro-dynamics (Slider/ Tensioner Technique)Upper limb Neuro-dynamics (Slider/Tensioner Technique) along with Task Oriented Training |
| Upper Limb Conventional Therapy | Active comparator | Other: Conventional Therapy for Upper limbStretching, Strengthening exercises along with Task Oriented Training |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Upper Limb Neurodynamics Group |
| Conventional Therapy for Upper limbConventional 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. | Other | Upper Limb Conventional Therapy |
Primary outcome
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.
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).
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).
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abrish Habib Abbasi, MS-NMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper limb Neuro-dynamics (Slider/ Tensioner Technique) and Conventional Therapy for Upper limb in people with Pronator Teres Syndrome, run by Riphah International University at 1 site in Pakistan.
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 2 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: finished, as of the sponsor's last update on 15 Aug 2024. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric visual analogue scale (VAS) (time frame: 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2024.