Carpal Tunnel SyndromeNCT04969393
Effects of High Intensity Laser on Mechanical and Physiological Findings in Pregnant Women With Carpal Tunnel Syndrome
A study testing High intensity laser therapy and Conventional Physical Therapy in people with Carpal Tunnel Syndrome and Pregnancy Related, run by October 6 University at 1 site in Egypt.
Trial summary
This study will propose a novel approach to treat pregnant women with mild to moderate carpal tunnel syndrome (CTS) using the recently introduced High intensity laser therapy with its deep penetration and high-power characteristics. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Pregnancy Related
- What is being tested?
- High intensity laser therapy and Conventional Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2021to 30 Jul 2021
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with mild to moderate CTS diagnosed by a physician according to the American Association of Electrodiagnostic recent guidelines [18] (2) The age ranged between 20 to 40 years (3) Had positive clinical provocative tests for the CTS (Tinel test and Phalen test) and (5) Had a history of pain, paresthesia or numbness in the median nerve distribution, nocturnal pain, and night waking
Who cannot join
- Patients were excluded from the study if they had cervical disc prolapse, cervical spondylosis, thoracic outlet syndrome, diabetes, gestational diabetes, cardiovascular disorders and hypertension. Patients who had carpal tunnel release surgery and patients who were diagnosed with CTS before pregnancy were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
October 6 University Hospital
Al Ḩayy Ath Thāmin, Giza Governorate, 12511
About this study
Official title: Effects of High Intensity Laser on Mechanical and Physiological Findings in Pregnant Women With Carpal Tunnel Syndrome: A Randomized Controlled Trial
This study will propose a novel approach to treat pregnant women with mild to moderate carpal tunnel syndrome (CTS) using the recently introduced High intensity laser therapy with its deep penetration and high-power characteristics. It's hopeful that the results of this study can fill the gap of knowledge surrounding the conservative treatment options for CTS in order to help patients restore their nerve function properly and promote new ways of addressing CTS.
- Conditions
- Carpal Tunnel Syndrome, Pregnancy Related
- Being tested
- High intensity laser therapy, Conventional Physical Therapy
- Keywords
- carpal tunnel syndrome, high intensity laser therapy, electrophysiology, pregnant women
- 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.
High intensity laser therapyDevice
Also called High power laser therapy
Fifteen treatment sessions with pulsed Nd: YAG laser were applied to the subjects of the study group, three sessions per week, over 5 weeks in succession via EXAND MY 1064 nm Laser system, Mectronic Medicale, Italy. Patients in group (A) received HILT along with the conventional physical therapy program. The session involved 3 subphases: (1) The Initial phase "Analgesic phase", (2) In the intermediate phase "Trigger point phase"and (3)The final phase "Bio-stimulation phase" was applied for 6 minutes with a slow scanning in several parallel longitudinal lines.
Conventional Physical TherapyOther
Also called Standard Physiotherapy
Fifteen treatment sessions that involved using a neutral custom volar splint alongside neural and tendon gliding exercises. the splint was used at night and while performing strenuous activities during the day for 5 weeks. While nerve and tendon gliding exercises was repeated 10 times at each session and patients were encouraged to apply exercise 3-5 times per day for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A (High Intensity Laser therapy + Conventional Physical Therapy) | Experimental | Patients in group (A) received conventional physical therapy program along with HILT. Patients received pulsed Nd: YAG laser treatment, produced by EXAND MY 1064 nm Laser system, Mectronic Medicale, Italy. The apparatus provided pulsed emission (1064 nm), very high peak power (3 kW), a high level of fluency (energy density; 360-1780 mJ/cm2). Receives: Device: High intensity laser therapy; Other: Conventional Physical Therapy |
| Group B (Conventional Physical Therapy) | Active comparator | Patients in this group received the conventional physical therapy program in the form of splinting, tendon and neural gliding exercises. Patients were instructed to wear a neutral custom volar splint at night and while performing strenuous activities during the day for 5 weeks.Also, the patients performed nerve-and tendon-gliding exercise under direct supervision of the therapist during the treatment sessions. Each exercise was repeated 10 times at each session and patients were encouraged to apply exercise 3-5 times per day for 5 weeks. Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Distal latency of median nerve sensory distal latency
The Median sensory nerve (SNDL) distal latency was measured according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines with a Neuropack S1 MEB-9004 Nihon Koden (Japan). All measurements were performed in a room with the temperature kept at 25C.
Measured: Baseline and after 5 Weeks
Changes in Distal latency of median nerve motor distal latency
The Median motor nerve (MNDL) distal latency was measured according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines with a Neuropack S1 MEB-9004 Nihon Koden (Japan). All measurements were performed in a room with the temperature kept at 25C.
Measured: Baseline and after 5 Weeks
Secondary outcomes (2)
Changes in hand grip strength
The hand grip strength (measured in Kilograms) was evaluated by the same investigator. Grip strength was tested by using Jamar hand held dynamometer following the American Society of Hand Therapists guidelines. The patient's arm was positioned with the shoulder adducted and neutrally rotated, the elbow was flexed at 90, the forearm and wrist were neutrally positioned while the participant was sitting. Patients were instructed to squeeze the handle as hard as they could, do maximal grip contraction for 2-5 s.
Measured: Baseline and after 5 Weeks
Changes in numeric pain rating scale (NPRS)
An 11-point Numerical Pain Rating Scale (NPRS; 0 = no pain, 10 = maximum pain) was used to assess the patients' levels of hand pain pre and post treatment.
Measured: Baseline and after 5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start30 Apr 2021
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy Ali Hassan ElMeligie, October 6 University
- Investigators
- Abeer F Hanafy, Ph.D, Study chair, Cairo UniversityRadwa M Yehia, Ph.D, Study director, Faculty of Physical Therapy, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969393
- Sponsor's protocol ID
- HILTPCTS2021
- Status last verified
- Sep 2021
- First submitted
- 9 Jul 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all of the individual participant data collected during the trial and after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Laser on Mechanical and Physiological Findings in Pregnant Women With Carpal Tunnel Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04969393
- Acronym / sponsor ID
- HILTPCTS2021
- Conditions
- Carpal Tunnel Syndrome, Pregnancy Related
- Keywords
- carpal tunnel syndrome, high intensity laser therapy, electrophysiology, pregnant women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 20 Jul 2021 (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.
This study will propose a novel approach to treat pregnant women with mild to moderate carpal tunnel syndrome (CTS) using the recently introduced High intensity laser therapy with its deep penetration and high-power characteristics. It's hopeful that the results of this study can fill the gap of knowledge surrounding the conservative treatment options for CTS in order to help patients restore their nerve function properly and promote new ways of addressing CTS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (High Intensity Laser therapy + Conventional Physical Therapy) | Experimental | Device: High intensity laser therapy, Other: Conventional Physical TherapyPatients in group (A) received conventional physical therapy program along with HILT. Patients received pulsed Nd: YAG laser treatment, produced by EXAND MY 1064 nm Laser system, Mectronic Medicale, Italy. The apparatus provided pulsed emission (1064 nm), very high peak power (3 kW), a high level of fluency (energy density; 360-1780 mJ/cm2). |
| Group B (Conventional Physical Therapy) | Active comparator | Other: Conventional Physical TherapyPatients in this group received the conventional physical therapy program in the form of splinting, tendon and neural gliding exercises. Patients were instructed to wear a neutral custom volar splint at night and while performing strenuous activities during the day for 5 weeks.Also, the patients performed nerve-and tendon-gliding exercise under direct supervision of the therapist during the treatment sessions. Each exercise was repeated 10 times at each session and patients were encouraged to apply exercise 3-5 times per day for 5 weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women with mild to moderate CTS diagnosed by a physician according to the American Association of Electrodiagnostic recent guidelines [18] (2) The age ranged between 20 to 40 years (3) Had positive clinical provocative tests for the CTS (Tinel test and Phalen test) and (5) Had a history of pain, paresthesia or numbness in the median nerve distribution, nocturnal pain, and night waking
Key exclusion criteria (1 listed)
- Patients were excluded from the study if they had cervical disc prolapse, cervical spondylosis, thoracic outlet syndrome, diabetes, gestational diabetes, cardiovascular disorders and hypertension. Patients who had carpal tunnel release surgery and patients who were diagnosed with CTS before pregnancy were also excluded from the study.
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 |
|---|---|---|
| High intensity laser therapyAlso: High power laser therapyFifteen treatment sessions with pulsed Nd: YAG laser were applied to the subjects of the study group, three sessions per week, over 5 weeks in succession via EXAND MY 1064 nm Laser system, Mectronic Medicale, Italy. Patients in group (A) received HILT along with the conventional physical therapy program. The session involved 3 subphases: (1) The Initial phase "Analgesic phase", (2) In the intermediate phase "Trigger point phase"and (3)The final phase "Bio-stimulation phase" was applied for 6 minutes with a slow scanning in several parallel longitudinal lines. | Device | Group A (High Intensity Laser therapy + Conventional Physical Therapy) |
| Conventional Physical TherapyAlso: Standard PhysiotherapyFifteen treatment sessions that involved using a neutral custom volar splint alongside neural and tendon gliding exercises. the splint was used at night and while performing strenuous activities during the day for 5 weeks. While nerve and tendon gliding exercises was repeated 10 times at each session and patients were encouraged to apply exercise 3-5 times per day for 5 weeks. | Other | Group A (High Intensity Laser therapy + Conventional Physical Therapy), Group B (Conventional Physical Therapy) |
Primary outcome
Changes in Distal latency of median nerve sensory distal latency
Time frame: Baseline and after 5 Weeks
The Median sensory nerve (SNDL) distal latency was measured according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines with a Neuropack S1 MEB-9004 Nihon Koden (Japan). All measurements were performed in a room with the temperature kept at 25C.
Changes in Distal latency of median nerve motor distal latency
Time frame: Baseline and after 5 Weeks
The Median motor nerve (MNDL) distal latency was measured according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines with a Neuropack S1 MEB-9004 Nihon Koden (Japan). All measurements were performed in a room with the temperature kept at 25C.
2 secondary outcomes
Changes in hand grip strength
Time frame: Baseline and after 5 Weeks
Changes in numeric pain rating scale (NPRS)
Time frame: Baseline and after 5 Weeks
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 9 Sep 2021.
- Individual participant dataSharing planned: Yes. all of the individual participant data collected during the trial and after deidentification
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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.
Abeer F Hanafy, Ph.D study chair
Cairo University
Radwa M Yehia, Ph.D study director
Faculty of Physical Therapy, October 6 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 High intensity laser therapy and Conventional Physical Therapy in people with Carpal Tunnel Syndrome and Pregnancy Related, run by October 6 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 1 inclusion and 1 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 9 Sep 2021. 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?
Changes in Distal latency of median nerve sensory distal latency (time frame: Baseline and after 5 Weeks). The study lists 2 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 9 Sep 2021.