NCT05671523

Brief Summary

This study will be conducted to investigate the effect of dry needling on quality of life in patients with trigger finger

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

December 14, 2022

Last Update Submit

September 11, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    up to five weeks

  • Hand grip strength

    Hand grip strength will be assessed by Hand grip dynamometer

    up to five weeks

Study Arms (2)

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.)

Procedure: Dry needlingOther: conventional treatment

conventional treatment

ACTIVE COMPARATOR

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

Other: conventional treatment

Interventions

Dry needlingPROCEDURE

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.

Dry needling

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.

Dry needlingconventional treatment

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damanhour teaching hospital

Damanhūr, Egypt

Location

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Eman Em El halawany

    Damanhour Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 14, 2022

First Posted

January 4, 2023

Study Start

January 1, 2023

Primary Completion

June 10, 2023

Study Completion

June 10, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations