Muscle Weakness ConditionNCT04645758
A Study to Analyse the Immediate Effect of Dry Needling and Extra Corporeal Shock Wave Therapy on Hand Grip Strength
A study testing Dry needling and Extra corporeal Shock wave therapy in people with Muscle Weakness Condition, run by Comprehensive Rehabilitation Centre, Medina, Saudi Arabia at 1 site in Saudi Arabia.
Trial summary
An argument to analyse the Immediate effect of dry needling or extra corporeal shock wave therapy on hand grip strength in normal healthy individuals with a hypothesis of dry needling or shock wave on forearm muscles have influence on the hand grip strength. Read more about this study
- Who is it for?
- Ages 21 to 46 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness Condition
- What is being tested?
- Dry needling and Extra corporeal Shock wave therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 29 Nov 2020to 29 Nov 2020
- 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 21 to 46 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No pain on the visual analog scoring scale of 100 mm scale,
- Muscle power of 4+ on oxford manual muscle testing of forearm and wrist extrinsic and intrinsic muscles
- Full range of motion in all dominant upper extremity joints.
Who cannot join
- History of previous fractures of the dominant upper extremity,
- Teno-synovitis of flexor tendons ,
- Dequervains synovitis,
- Left hand dominance.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Comprehensive Rehabilitation Centre
Madinah, 42381
Mohammed A Khan, 0508921749, amjadkhan.mmkk@gmail.com
Rayan M Al-Fadani, BPT
About this study
Official title: The Immediate Effects of Dry Needling and Extra Corporeal Shockwave Therapy on Hand Grip Strength.A Randomised Controlled Trail.
An argument to analyse the Immediate effect of dry needling or extra corporeal shock wave therapy on hand grip strength in normal healthy individuals with a hypothesis of dry needling or shock wave on forearm muscles have influence on the hand grip strength.
Read the detailed description
After written consent obtained from all the participants randomization and allocation will be done with sealed non transparent envelopes and participants will be assign to two groups Dry needling(DN) and Extra corporeal shock wave therapy (ESWT).Pre and post data of hand grip strength measured with Jamar hand dynamometer.Post data shall be collected precisely after 1 hr of intervention from both groups.
- Conditions
- Muscle Weakness Condition
- Being tested
- Dry needling and Extra corporeal Shock wave therapy
- Keywords
- Dry needling, Extra corporeal Shockwave therapy, Hand Grip Strength, Post 1 hour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needling and Extra corporeal Shock wave therapyCombination product
Also called Dry needle/Acupuncture needle.Shock wave therapy
5 mins of dry needling and 1250 pulses of shockwave therapy on dominant forearm muscles
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling Group or (DN) | Active comparator | Dry needling for 5 mins on the flexor group of muscles of dominant forearm. Receives: Combination Product: Dry needling and Extra corporeal Shock wave therapy |
| Extra corporeal Shockwave therapy Group or (ESWT) | Active comparator | Delivering of Shock wave pulses of 1250 at the energy intensity of 0.58 mj/mm2 on the flexor group of muscles of dominant forearm Receives: Combination Product: Dry needling and Extra corporeal Shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Grip Strength
Measurement of Hand Grip Strength with Jamar Dynamometer
Measured: Post 1 hours of Intervention in both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start29 Nov 2020
- Primary completion29 Nov 2020
- Study completion29 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Weakness ConditionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to two groups in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comprehensive Rehabilitation Centre, Medina, Saudi Arabia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rayan Mohammed Al Fadani, Comprehensive Rehabilitation Centre, Medina, Saudi Arabia
- Investigators
- Rayan M Al-Fadani, BPT, Principal investigator, Comprehensive rehabilitation centre, Medina Al Munawwarah, Saudi Arabia.Abdullah M Al-Shenqiti, PhD,PT, Study director, Taibah University of Medical Rehabilitation SciencesTarek M El-Gohary, PhD,PT, Study chair, Taibah University of Medical Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645758
- Sponsor's protocol ID
- Rct001
- Status last verified
- Nov 2020
- First submitted
- 22 Sep 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results of Hand grip strength pre and post intervention.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effects of Dry Needling and Extra Corporeal Shockwave Therapy on Hand Grip Strength.A Randomised Controlled Trail.
- ClinicalTrials.gov ID
- NCT04645758
- Acronym / sponsor ID
- Rct001
- Conditions
- Muscle Weakness Condition
- Keywords
- Dry needling, Extra corporeal Shockwave therapy, Hand Grip Strength, Post 1 hour
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Comprehensive Rehabilitation Centre, Medina, Saudi ArabiaUniversity, hospital or other
- Study start
- 29 Nov 2020 (actual)
- Primary completion
- 29 Nov 2020 (actual)
- Study completion
- 29 Nov 2020 (estimated)
- First posted
- 27 Nov 2020 (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.
An argument to analyse the Immediate effect of dry needling or extra corporeal shock wave therapy on hand grip strength in normal healthy individuals with a hypothesis of dry needling or shock wave on forearm muscles have influence on the hand grip strength.
Detailed description
After written consent obtained from all the participants randomization and allocation will be done with sealed non transparent envelopes and participants will be assign to two groups Dry needling(DN) and Extra corporeal shock wave therapy (ESWT).Pre and post data of hand grip strength measured with Jamar hand dynamometer.Post data shall be collected precisely after 1 hr of intervention from both groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Dry Needling Group or (DN) | Active comparator | Combination Product: Dry needling and Extra corporeal Shock wave therapyDry needling for 5 mins on the flexor group of muscles of dominant forearm. |
| Extra corporeal Shockwave therapy Group or (ESWT) | Active comparator | Combination Product: Dry needling and Extra corporeal Shock wave therapyDelivering of Shock wave pulses of 1250 at the energy intensity of 0.58 mj/mm2 on the flexor group of muscles of dominant forearm |
Who may qualify
- Ages
- 21 to 46 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No pain on the visual analog scoring scale of 100 mm scale,
- Muscle power of 4+ on oxford manual muscle testing of forearm and wrist extrinsic and intrinsic muscles
- Full range of motion in all dominant upper extremity joints.
Key exclusion criteria (4 listed)
- History of previous fractures of the dominant upper extremity,
- Teno-synovitis of flexor tendons ,
- Dequervains synovitis,
- Left hand dominance.
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 |
|---|---|---|
| Dry needling and Extra corporeal Shock wave therapyAlso: Dry needle/Acupuncture needle.Shock wave therapy5 mins of dry needling and 1250 pulses of shockwave therapy on dominant forearm muscles | Combination product | Dry Needling Group or (DN), Extra corporeal Shockwave therapy Group or (ESWT) |
Primary outcome
Hand Grip Strength
Time frame: Post 1 hours of Intervention in both groups
Measurement of Hand Grip Strength with Jamar Dynamometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Individual participant dataSharing planned: No. Results of Hand grip strength pre and post intervention.
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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.
Rayan M Al-Fadani, BPT principal investigator
Comprehensive rehabilitation centre, Medina Al Munawwarah, Saudi Arabia.
Abdullah M Al-Shenqiti, PhD,PT study director
Taibah University of Medical Rehabilitation Sciences
Tarek M El-Gohary, PhD,PT study chair
Taibah University of Medical Rehabilitation Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling and Extra corporeal Shock wave therapy in people with Muscle Weakness Condition, run by Comprehensive Rehabilitation Centre, Medina, Saudi Arabia at 1 site in Saudi Arabia.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Dec 2020. 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed A Khan, BPT (00966508921749, amjadkhan.mmkk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Grip Strength (time frame: Post 1 hours of Intervention in both groups). 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 1 Dec 2020.