- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05671523
Effect Of Dry Needling On Quality Of Life In Patients With Trigger Fingers
Effect Of Dry Needling On Quality Of Life In Patients With Trigger Fingers. Randomized Controlled Trail
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abeer Abd El Rahman yamany, Professor
- Phone Number: 01006899872
- Email: abeer.yamany@pt.cu.edu.eg
Study Contact Backup
- Name: Hanaa kenawy Atta, Lecturer
- Phone Number: 01008320656
- Email: h_k90girl@yahoo.com
Study Locations
-
-
-
Damanhūr, Egypt
- Damanhour Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dry needling
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.)
|
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.
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. |
Active Comparator: conventional treatment
The patients will receive conventional treatment (splinting and ultrasound therapy) for 5 weeks
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to five weeks
|
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.
|
up to five weeks
|
Hand grip strength
Time Frame: up to five weeks
|
Hand grip strength will be assessed by Hand grip dynamometer
|
up to five weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eman Em El halawany, Damanhour Teaching Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- p.t.REC/012/003924
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trigger Finger Disorder
-
Stanford UniversityTerminatedTrigger Finger | Trigger Finger Disorder | Trigger Thumb | Trigger Digit | Trigger Thumb, Left Thumb | Trigger Thumb, Right Thumb | Trigger Finger, Ring Finger | Trigger Finger, Index Finger | Trigger Finger, Middle Finger | Trigger Finger, Little Finger | Trigger Thumb, Unspecified Thumb | Trigger Finger, Unspecified...United States
-
Brigham and Women's HospitalCompletedTrigger FingerUnited States
-
National and Kapodistrian University of AthensCompletedSurgical Release of Ai Pulley Trigger Finger
-
Gaziler Physical Medicine and Rehabilitation Education...Completed
-
Waikato HospitalEnrolling by invitation
-
Armed Police Force Hospital, NepalCompleted
-
Sorin Daniel IordacheCompleted
-
Sharp HealthCareUniversity of UtahCompleted
-
Vanderbilt University Medical CenterCompletedTrigger FingerUnited States
-
Ericka LawlerCompletedTrigger Finger DisorderUnited States
Clinical Trials on Dry needling
-
Brigham Young UniversityTerminatedMyofascial Pain Syndrome | Myofascial Trigger Point PainUnited States
-
Army-Baylor University Doctoral Program in Physical...Brooke Army Medical CenterCompletedChronic Pain | Shoulder Pain | Musculoskeletal InjuryUnited States
-
Youngstown State UniversityRecruiting
-
Universidad de ZaragozaCompleted
-
Institute of Technology, CarlowCompleted
-
Universidad de ZaragozaUnknownHip OsteoarthritisSpain
-
Universitat Internacional de CatalunyaRecruitingMyofascial Trigger Point PainSpain
-
University of HaifaCompleted
-
Texas Woman's UniversityActive, not recruitingShoulder Pain | Dry NeedlingUnited States
-
Baylor UniversityTelemedicine & Advanced Technology Research Center (TATRC); Army Medical Department...Completed