Trigger Finger DisorderNCT05671523
Effect Of Dry Needling On Quality Of Life In Patients With Trigger Fingers
A study testing Dry needling and conventional treatment in people with Trigger Finger Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the effect of dry needling on quality of life in patients with trigger finger Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Trigger Finger Disorder
- What is being tested?
- Dry needling and conventional treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 10 Jun 2023
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 patients all have trigger fingers lasting at least 4 weeks.
- Both gender will be included
- Age of patients will be 45-75 years old
- Pain and tenderness at the position of A1 pulley.
- Nodule palpation, pain, and discomfort when flexing and extending the finger, presence of a clicking sound at the time of flexion or extension of the finger, snapping or locking of the finger.
- Willing and able to complete study procedures.
Who cannot join
- Participants with diabetes mellitus.
- History of trauma, and rheumatoid arthritis.
- Dialysis treatment.
- fingers with a history of local gouty/pyogenic disease.
- Major hand trauma and fear of needles.
- Any contraindication for deep dry needling such as anticoagulants, infections, bleeding, or psychotic conditions tumors, calcium deposits, or severe osteoarthritis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Dry Needling On Quality Of Life In Patients With Trigger Fingers. Randomized Controlled Trail
This study will be conducted to investigate the effect of dry needling on quality of life in patients with trigger finger
Read the detailed description
Trigger finger (TF) is one of the most prevalent causes of hand disability and is a common cause of referral to orthopedic clinics. Trigger finger is tenosynovitis of the flexor sheaths that typically occurs in the 4th finger and thumb as a result of repetitive use. The incidence of TF is 28:100,000 per year or lifetime risk of 2.6% in the general population. It has the highest incidence being between 52 and 62 years more in women (75%). Thumb and fourth digit (ring finger) are the most commonly affected fingers.
Dry needling (DN) is a relatively new technique used by physical therapists to treat myofascial trigger points (MTrPs) and various pain syndromes. Dry needling is defined as a "skilled intervention using a thin filiform needle to penetrate the skin that stimulates myofascial TrPs, muscles, and connective tissue for the treatment of musculoskeletal pain disorders. DN has analgesic and anti-inflammatory effects, it is commonly used to relieve pain and reduce inflammation.
- Conditions
- Trigger Finger Disorder
- Being tested
- Dry needling, conventional treatment
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingProcedure or surgery
Firstly the skin is cleaned with a piece of cotton immersed in alcohol. Then sterilized disposable thin, stainless steel needles (25 × 0.30 mm) will be inserted into the skin over the nodule in A1 pulley anatomic location. The duration of needling will be 1 minute. The needle will be inserted deeply at 45° to the level of metacarpophalangeal level to the nodule. The needle may be inserted into the tendon. This is confirmed by needle movement when the patient flexes and extends the distal phalanx. The needle is withdrawn slowly until this motion ceases, and the needle tip is in the A1 pulley. This will be repeated 2 times per week for 5 weeks.
conventional treatmentOther
Finger splint is designed to stabilize and immobilize a small finger joint. A wide, flat band offers comfortable pressure distribution and control. Contoured finger splint with a comfortable, close fit. The patient will use the splint at night. Can easily be adjusted to accommodate swollen digits. Suitable for a number of finger conditions.
Therapeutic ultrasound is often used by physiotherapists to reduce pain, increase circulation and increase mobility of soft tissues. Additionally, the application of ultrasound can be helpful in the reduction of inflammation, reducing pain and the healing.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | The patients will receive ten sessions, twice a week, for five weeks of dry needling in addition to their conventional physical therapy program (splinting and ultrasound therapy.) Receives: Procedure: Dry needling; Other: conventional treatment |
| conventional treatment | Active comparator | The patients will receive conventional treatment (splinting and ultrasound therapy) for 5 weeks Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life quality
Quality of life will be assessed by quality of life questionnaire which is a broad concept that covers such areas as social, environmental, economic, and health satisfaction, health-related quality of life (HRQL) is less wide ranging, including mental and physical health and their consequences. Higher score denote higher quality of life and lower score denote lower quality of life. There are two methods for converting raw scores to transformed scores. The first transformation method converts score to range between 4-20,comparable with the WHOQOL-100. The second transformation method converts domain scores to a 0-100 scale.
Measured: up to five weeks
Severity of pain
severity of pain will be assessed by visual analogue scale. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). The patient will be asked to mark their current pain level on the line. They can also be asked to mark their maximum, minimum, and average pain. The examiner will score the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no pain" anchor point.
Measured: up to five weeks
Hand grip strength
Hand grip strength will be assessed by Hand grip dynamometer
Measured: up to five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Jan 2023
- Primary completion10 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger Finger DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Yamany, Ph. D., Cairo University
- Investigators
- Eman Em El halawany, Principal investigator, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671523
- Sponsor's protocol ID
- p.t.REC/012/003924
- Status last verified
- Sep 2023
- First submitted
- 14 Dec 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Dry Needling On Quality Of Life In Patients With Trigger Fingers. Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT05671523
- Acronym / sponsor ID
- p.t.REC/012/003924
- Conditions
- Trigger Finger Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 4 Jan 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.
This study will be conducted to investigate the effect of dry needling on quality of life in patients with trigger finger
Detailed description
Trigger finger (TF) is one of the most prevalent causes of hand disability and is a common cause of referral to orthopedic clinics. Trigger finger is tenosynovitis of the flexor sheaths that typically occurs in the 4th finger and thumb as a result of repetitive use. The incidence of TF is 28:100,000 per year or lifetime risk of 2.6% in the general population. It has the highest incidence being between 52 and 62 years more in women (75%). Thumb and fourth digit (ring finger) are the most commonly affected fingers.
Dry needling (DN) is a relatively new technique used by physical therapists to treat myofascial trigger points (MTrPs) and various pain syndromes. Dry needling is defined as a "skilled intervention using a thin filiform needle to penetrate the skin that stimulates myofascial TrPs, muscles, and connective tissue for the treatment of musculoskeletal pain disorders. DN has analgesic and anti-inflammatory effects, it is commonly used to relieve pain and reduce inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Procedure: Dry needling, Other: conventional treatmentThe patients will receive ten sessions, twice a week, for five weeks of dry needling in addition to their conventional physical therapy program (splinting and ultrasound therapy.) |
| conventional treatment | Active comparator | Other: conventional treatmentThe patients will receive conventional treatment (splinting and ultrasound therapy) for 5 weeks |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 40 patients all have trigger fingers lasting at least 4 weeks.
- Both gender will be included
- Age of patients will be 45-75 years old
- Pain and tenderness at the position of A1 pulley.
- Nodule palpation, pain, and discomfort when flexing and extending the finger, presence of a clicking sound at the time of flexion or extension of the finger, snapping or locking of the finger.
Key exclusion criteria (6 listed)
- Participants with diabetes mellitus.
- History of trauma, and rheumatoid arthritis.
- Dialysis treatment.
- fingers with a history of local gouty/pyogenic disease.
- Major hand trauma and fear of needles.
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 needlingFirstly the skin is cleaned with a piece of cotton immersed in alcohol. Then sterilized disposable thin, stainless steel needles (25 × 0.30 mm) will be inserted into the skin over the nodule in A1 pulley anatomic location. The duration of needling will be 1 minute. The needle will be inserted deeply at 45° to the level of metacarpophalangeal level to the nodule. The needle may be inserted into the tendon. This is confirmed by needle movement when the patient flexes and extends the distal phalanx. The needle is withdrawn slowly until this motion ceases, and the needle tip is in the A1 pulley. This will be repeated 2 times per week for 5 weeks. | Procedure or surgery | Dry needling |
| conventional treatmentFinger splint is designed to stabilize and immobilize a small finger joint. A wide, flat band offers comfortable pressure distribution and control. Contoured finger splint with a comfortable, close fit. The patient will use the splint at night. Can easily be adjusted to accommodate swollen digits. Suitable for a number of finger conditions. Therapeutic ultrasound is often used by physiotherapists to reduce pain, increase circulation and increase mobility of soft tissues. Additionally, the application of ultrasound can be helpful in the reduction of inflammation, reducing pain and the healing. | Other | Dry needling, conventional treatment |
Primary outcome
Life quality
Time frame: up to five weeks
Quality of life will be assessed by quality of life questionnaire which is a broad concept that covers such areas as social, environmental, economic, and health satisfaction, health-related quality of life (HRQL) is less wide ranging, including mental and physical health and their consequences. Higher score denote higher quality of life and lower score denote lower quality of life. There are two methods for converting raw scores to transformed scores. The first transformation method converts score to range between 4-20,comparable with the WHOQOL-100. The second transformation method converts domain scores to a 0-100 scale.
Severity of pain
Time frame: up to five weeks
severity of pain will be assessed by visual analogue scale. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). The patient will be asked to mark their current pain level on the line. They can also be asked to mark their maximum, minimum, and average pain. The examiner will score the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no pain" anchor point.
Hand grip strength
Time frame: up to five weeks
Hand grip strength will be assessed by Hand grip dynamometer
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 13 Sep 2023.
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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.
Eman Em El halawany principal investigator
Damanhour Teaching Hospital
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 conventional treatment in people with Trigger Finger Disorder, 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 6 inclusion and 6 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 13 Sep 2023. 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?
Life quality (time frame: up to five weeks). The study lists 3 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 13 Sep 2023.