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Effect Of Dry Needling On Quality Of Life In Patients With Trigger Fingers

Primary Purpose

Trigger Finger Disorder

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dry needling
conventional treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Finger Disorder

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Damanhour teaching hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry needling

conventional treatment

Arm Description

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.)

The patients will receive conventional treatment (splinting and ultrasound therapy) for 5 weeks

Outcomes

Primary Outcome Measures

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.
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.
Hand grip strength
Hand grip strength will be assessed by Hand grip dynamometer

Secondary Outcome Measures

Full Information

First Posted
December 14, 2022
Last Updated
September 11, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05671523
Brief Title
Effect Of Dry Needling On Quality Of Life In Patients With Trigger Fingers
Official Title
Effect Of Dry Needling On Quality Of Life In Patients With Trigger Fingers. Randomized Controlled Trail
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 10, 2023 (Actual)
Study Completion Date
June 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling
Arm Type
Experimental
Arm Description
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.)
Arm Title
conventional treatment
Arm Type
Active Comparator
Arm Description
The patients will receive conventional treatment (splinting and ultrasound therapy) for 5 weeks
Intervention Type
Procedure
Intervention Name(s)
Dry needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Life quality
Description
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.
Time Frame
up to five weeks
Title
Severity of pain
Description
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.
Time Frame
up to five weeks
Title
Hand grip strength
Description
Hand grip strength will be assessed by Hand grip dynamometer
Time Frame
up to five weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Em El halawany
Organizational Affiliation
Damanhour Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damanhour teaching hospital
City
Damanhūr
Country
Egypt

12. IPD Sharing Statement

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Effect Of Dry Needling On Quality Of Life In Patients With Trigger Fingers

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