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Carpal Tunnel Syndrome (CTS)FHPCTSNCT06942052

Correlation Between Forward Head Posture, Cervical Range of Motion, and Nerve Conduction Values in Carpal Tunnel Cases

An observational study of Carpal Tunnel Syndrome (CTS), run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Before the examination, participants underwent thorough preparation to guarantee the accuracy and reliability of the study's results. Each participant was provided with a comprehensive overview of the assessment procedures, highlighting the importance of the CVA measurements, NCS, cervical ROM evaluations, and the VAS… Read more about this study

Who is it for?
Ages 22 to 40 years
Conditions the study is for
Carpal Tunnel Syndrome (CTS)
How many people
119 participants
Where
1 siteEgypt
Study dates
12 Jun 2022to 20 Sep 2022
Phase
Observational
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 22 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: 119 Participants aged between 25 and 40 years from both genders were included in this study with the following criteria: (a) Participants reported pain and paresthesia in the median nerve distribution of the hand for a minimum of three months. (b) Symptoms were noted to worsen at night, (c) A positive Phalen sign (d) A positive Tinel sign [8] and (E) abnormal parameter of electrophysiological studies include prolonged distal motor latency exceeded 4.2 ms and prolonged distal sensory latency exceeded 3.6 ms.

Who may be able to join

  • 25 and 40 years
  • both genders
  • Participants reported pain and paresthesia in the median nerve distribution of the hand for a minimum of three months.
  • Symptoms were noted to worsen at night
  • A positive Phalen sign
  • A positive Tinel sign
  • abnormal parameter of electrophysiological studies include prolonged distal motor latency exceeded 4.2 ms and prolonged distal sensory latency exceeded 3.6 ms.

Who cannot join

  • individuals with current ulnar or radial nerve neuropathy.
  • Previous injection or release for carpal tunnel.
  • Patients with various upper extremity or cervical diseases, such as cervical radiculopathy.
  • Diabetic patients
  • pregnant females.
  • Patients who had previously undergone cervical surgery had a history of cervical fractures or trauma or had temporomandibular disorders.
  • Patients on antiepileptic medication for neuropathic pain
  • those with inflammatory or uncontrolled systemic disorders that cause neuropathy.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • faculty of physical therapy, Cairo University

    Cairo, P.O.Box 11432

Other trials in Egypt

About this study

Before the examination, participants underwent thorough preparation to guarantee the accuracy and reliability of the study's results. Each participant was provided with a comprehensive overview of the assessment procedures, highlighting the importance of the CVA measurements, NCS, cervical ROM evaluations, and the VAS for assessing pain levels. They were advised to come well-rested and to refrain from any activities that could affect their pain levels or overall physical condition on the assessment day. Furthermore, participants were encouraged to wear comfortable attire to facilitate the examination process. Ensuring a supportive environment was essential, allowing participants to feel at ease while discussing their symptoms and experiences, which is vital for collecting accurate data and fostering cooperation throughout the study.

Read the detailed description

Participants in this study were referred from the neurophysiology unit at Al-Azhar University Hospital in New Damietta, as well as from the outpatient neurology clinic at Cairo University. The research was conducted at the outpatient clinic of the Faculty of Physical Therapy at Horus University in Damietta. Approval for the study was granted by the ethical committee of Cairo University's Faculty of Physical Therapy, with the approval number P.T.REC/012/003566. All participants provided written consent after a comprehensive explanation of the study's objectives, procedures, potential benefits, privacy considerations, and data utilization.

Sample size determination:

In this case-control study, we aimed to investigate the relationship between exposure and the outcome of interest by analyzing a total of 119 participants, divided into two groups: 84 individuals diagnosed with CTS and 35 controls exhibiting forward head posture. The proportions of exposed individuals were calculated, revealing that approximately 28.57% of the control group and 35.29% of the study group were exposed to the risk factor. The odds ratio (OR) was determined to be 1.3625, indicating that the odds of exposure were about 1.36 times higher in the CTS group compared to the controls. The 95% confidence interval for the OR ranged from 0.576 to 3.21, suggesting a positive association between exposure and the outcome, although the interval includes values less than 1, indicating that the association may not be statistically significant. All participants underwent a CVA with scores below 49 degrees, and NCS were performed to gather relevant values. Additionally, cervical ROM measurements were taken, and pain levels were evaluated using the VAS, while BMI was calculated for each participant.

Participants' Selection:

The study included a total of 119 participants, comprising 35 healthy individuals matched for age and sex, as well as 84 patients diagnosed with carpal tunnel syndrome. All participants exhibited FHP. The CTS patients were diagnosed based on medical assessment by neurologist and confirmed by electrophysiological studies (NCS).

Inclusion criteria:

119 Participants aged between 25 and 40 years from both genders were included in this study with the following criteria: (a) Participants reported pain and paresthesia in the median nerve distribution of the hand for a minimum of three months. (b) Symptoms were noted to worsen at night, (c) A positive Phalen sign (d) A positive Tinel sign [8] and (E) abnormal parameter of electrophysiological studies include prolonged distal motor latency exceeded 4.2 ms and prolonged distal sensory latency exceeded 3.6 ms.

Exclusion criteria:

Participants who had any of the following symptoms were excluded: individuals with current ulnar or radial nerve neuropathy. Previous injection or release for carpal tunnel. Patients with various upper extremity or cervical diseases, such as cervical radiculopathy. Diabetic patients and pregnant females. Patients who had previously undergone cervical surgery had a history of cervical fractures or trauma or had temporomandibular disorders. Patients on antiepileptic medication for neuropathic pain, those with inflammatory or uncontrolled systemic disorders that cause neuropathy.

Procedures:

Before the examination, participants underwent thorough preparation to guarantee the accuracy and reliability of the study's results. Each participant was provided with a comprehensive overview of the assessment procedures, highlighting the importance of the CVA measurements, NCS, cervical ROM evaluations, and the VAS for assessing pain levels. They were advised to come well-rested and to refrain from any activities that could affect their pain levels or overall physical condition on the assessment day. Furthermore, participants were encouraged to wear comfortable attire to facilitate the examination process. Ensuring a supportive environment was essential, allowing participants to feel at ease while discussing their symptoms and experiences, which is vital for collecting accurate data and fostering cooperation throughout the study.

Demographic data collection:

The demographic data were collected, including age, sex, weight, height, and body mass index BMI. BMI was calculated using the following equation: (Weight (Kg))/(Height (m^2))

Assessment of pain intensity using the VAS:

The participants were directed to draw a mark on a 10 cm line. This line shows a scale from no pain (zero) to the worst pain the patient could experience (ten). The patients' pain intensity was determined by recording measurements from the scale's zero point to their marks. [13] VAS scores of 3.4 or lower were classified as mild pain, scores ranging from 3.5 to 7.4 indicated moderate pain, and scores of 7.5 or higher were categorized as severe pain.

Assessment of CTS using phalen test:

A positive Phalen sign was present, indicating that symptoms intensified when the wrists were flexed for a specific duration (2 MIN) if numbness appear in 10 sec this means sever CTS, if numbness appear after 30 sec to 1min. means moderate, if symptoms appear after 1min. mean mild CTS.

Assessment of CTS using Tinel sign:

A positive Tinel sign was also observed when tapping over the median nerve at the wrist, which elicited tingling or pain in the median nerve distribution of the hand mainly palmar surface of lateral 3.5 fingers.

Assessment of cervical range of motion using CROM device:

The participants were guided to sit up straight in a comfortable position with their heads in a neutral position by looking straight forward. Only the head should be moved during the assessment, from forward to backward (flexion and extension), right/left rotation, and right/left lateral flexion, as far as they could do so without experiencing any pain. Three measurements were taken for each motion, and the mean was calculated for the statistical tests.

Assessment of forward head posture:

The forward head position was evaluated by photographing the participants' cervical region from the side and measuring the CVA. A plastic-colored marker was attached directly over the C7 vertebra's spinous process, and the tragus of the ear was marked. The camera was positioned 1.5 meters away from the participants on a stationary base without rotation or tilt, with the base set at the participants' shoulder height. To standardize the participants' neck posture, a self-balanced position was selected. The participants were told to keep their arms by their sides and to focus their vision on a point on the wall directly ahead of them.

In the current study, the CVA was calculated using the Kinovea software by measuring the angle between a line that runs from the tragus of the ear to C7 and a horizontal line that passes through C7. A smaller CVA suggested a higher FHP. The forward head position was considered if the CVA was less than 49 degrees.

Nerve conduction studies:

A neurophysiologist evaluated the electrophysiological results using the Neuropack Nihon Kohden Electrodiagnostic system at Al-Azhar University in New Damietta's Neurophysiology Department. Using standardized techniques, conduction tests of the median nerve were evaluated in both upper extremities. Nerve conduction values were obtained; CTS was defined as sensory distal latency (SDL) of 3.6 ms or more, sensory nerve conduction velocity (SNCV) is 45 m/sec or less, or motor distal latency (MDL) is 4.2 ms or more, and Motor nerve conduction velocity (MNCV) is 45 m/s or less.

Motor conduction studies:

The active recording electrode was placed directly over the thenar muscle (the belly of the abductor pollicis brevis muscle), the reference electrode was placed on the bony prominence at the base of the thumb. The ground electrode was firmly fixed on the dorsum of the hand, between the active and stimulating electrodes.

Distal stimulation was performed at the wrist between the flexor carpi radialis and palmaris longus tendons. Proximal stimulation was performed proximal and medial to the antecubital space medial to the bicep's tendon. The stimulator was placed immediately lateral to the brachial artery to reduce the chance of accidentally electro-stimulating the ulnar nerve.

Sensory conduction studies (Antidromic):

Ring electrodes were used. The active electrode was attached to the proximal segment of the index finger. The reference electrode was positioned on the distal phalanx 3 to 4 cm away from the active electrode. The ground was placed on the dorsal aspect of the hand between the active and stimulating electrodes. Ring electrodes are designed to provide a stable and consistent contact area for recording sensory nerve action potentials. Unlike surface electrodes, which may have variable contact quality, ring electrodes ensure uniform pressure and positioning, which can enhance the accuracy of the measurements. Stimulation was performed at the wrist in the same way as the motor conduction studies.

Keywords
forward head posture, cervical range of motion, nerve conduction velocity
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

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

Study groups in NCT06942052
Study groupRoleWhat they receive
study group consisted of 84 individuals diagnosed with CTSThe study group consisted of 84 individuals diagnosed with CTS, participants exhibiting forward head posture. All participants had a CVA score of less than 49 degrees. NCS were conducted on both groups to gather relevant NCS values, and measurements of cervical ROM were also taken. Additionally, the visual analog scale (VAS) was utilized to evaluate pain levels, and the body mass index (BMI) for each participant was calculated.
control group included 35 participantscontrol group included 35 participants exhibiting forward head posture. All participants had a CVA score of less than 49 degrees. NCS were conducted on to gather relevant NCS values, and measurements of cervical ROM were also taken. Additionally, the visual analog scale (VAS) was utilized to evaluate pain levels, and the body mass index (BMI) for each participant was calculated.

What is being measured

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

  1. visual analogue scale

    The participants were directed to draw a mark on a 10 cm line. This line shows a scale from no pain (zero) to the worst pain the patient could experience (ten). The patients' pain intensity was determined by recording measurements from the scale's zero point to their marks. VAS scores of 3.4 or lower were classified as mild pain, scores ranging from 3.5 to 7.4 indicated moderate pain, and scores of 7.5 or higher were categorized as severe pain.

    Measured: at the baseline

Secondary outcomes (4)
  1. phalen test

    A positive Phalen sign was present, indicating that symptoms intensified when the wrists were flexed for a specific duration (2 MIN) if numbness appear in 10 sec this means sever CTS, if numbness appear after 30 sec to 1min. means moderate, if symptoms appear after 1min. mean mild CTS.

    Measured: at the baseline

  2. Tinel sign

    A positive Tinel sign was also observed when tapping over the median nerve at the wrist, which elicited tingling or pain in the median nerve distribution of the hand mainly palmar surface of lateral 3.5 fingers.

    Measured: measurements were obtained at the time f the study

  3. forward head posture

    The forward head position was evaluated by photographing the participants' cervical region from the side and measuring the CVA. A plastic-colored marker was attached directly over the C7 vertebra's spinous process, and the tragus of the ear was marked. The camera was positioned 1.5 meters away from the participants on a stationary base without rotation or tilt, with the base set at the participants' shoulder height. To standardize the participants' neck posture, a self-balanced position was selected. The participants were told to keep their arms by their sides and to focus their vision on a point on the wall directly ahead of them.

    In the current study, the CVA was calculated using the Kinovea software by measuring the angle between a line that runs from the tragus of the ear to C7 and a horizontal line that passes through C7. A smaller CVA suggested a higher FHP. The forward head position was considered if the CVA was less than 49 degrees.

    Measured: at the baseline

  4. Nerve conduction studies

    A neurophysiologist evaluated the electrophysiological results using the Neuropack Nihon Kohden Electrodiagnostic system at Al-Azhar University in New Damietta's Neurophysiology Department. Using standardized techniques, conduction tests of the median nerve were evaluated in both upper extremities. Nerve conduction values were obtained; CTS was defined as sensory distal latency (SDL) of 3.6 ms or more, sensory nerve conduction velocity (SNCV) is 45 m/sec or less, or motor distal latency (MDL) is 4.2 ms or more, and Motor nerve conduction velocity (MNCV) is 45 m/s or less.

    Measured: at the baseline

Timeline

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

  1. First posted24 Apr 2025
  2. Study start12 Jun 2022
  3. Primary completion15 Aug 2022
  4. Study completion20 Sep 2022

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-control
Time perspective
Retrospective
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06942052
Sponsor's protocol ID
P.T.REC/012/003566
Acronym
FHPCTS
Status last verified
Apr 2025
First submitted
15 Apr 2025
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: it will be available when needed

Publications

  • Elfahl AM, Abd El Baky AM, Yousef MT, Elgohary HM. High Versus Low Frequency Transcutaneous Electric Nerve Stimulation On Chronic Venous Lower Limb Ulceration Randomized Controlled Trial. Int J Low Extrem Wounds. 2025 Jun;24(2):376-382. doi: 10.1177/15347346221093860. Epub 2022 Apr 14.

    PubMed 35422171

Questions about this trial

What is this clinical trial studying?

An observational study of Carpal Tunnel Syndrome (CTS), 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 7 inclusion and 8 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 24 Apr 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?

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?

visual analogue scale (time frame: at the baseline). 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 NCT06942052, which also lists 1 linked publication.

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 24 Apr 2025; AzTrials last refreshed its copy on 2 Nov 2026.

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