NCT07128043

Brief Summary

Objective: This study aimed to evaluate the efficacy of cassava wax hand immersion combined with ultrasound therapy on pain severity, pain threshold, finger locking frequency, and hand functional ability in patients with trigger finger. We assessed immediate, short-term, and long-term treatment outcomes. Methods: This was a randomized controlled trial. Thirty-eight eligible volunteers were randomly assigned to two groups. The experimental group received ultrasound therapy combined with cassava wax hand immersion, while the control group received ultrasound therapy alone. Treatments were administered three times per week for four weeks.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

July 31, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

29 days

First QC Date

July 31, 2025

Last Update Submit

August 13, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Visual Analog Scale (VAS)

    This assesses the current pain severity using a 10-centimeter scale. Scores range from 0 to 10, where the far left end of the scale indicates "no pain at all" (score of 0), and the far right end indicates "worst pain imaginable" (score of 10). Participants were asked to mark an 'X' on the scale at the point corresponding to their current pain severity.

    - Time 1: Baseline or Day 1 - Time 2:After treatment, the first time of immediate effect - Time 3: After treatments in 4 weeks - Time 4: 1 month after finishing treatments in 4 weeks.

  • Pressure pain threshold

    Participants were seated, and the assessor identified the location of the myofascial trigger point. This spot was marked with a washable pen. An algometer (a device used to measure pain threshold) was then applied to the marked trigger point at a rate of approximately 1 kg/second. Participants were instructed to signal immediately upon feeling the onset of pain (pain threshold). The applied pressure ranged from 0 to 11 kg/cm. Each participant underwent three measurements, with a 3-minute rest interval between each. The average of these three measurements was then calculated.

    - Time 1: Baseline or Day 1 - Time 2:After treatment, the first time of immediate effect - Time 3: After treatments in 4 weeks - Time 4: 1 month after finishing treatments in 4 weeks.

  • Pain frequency

    Participants were interviewed regarding the frequency of finger locking symptoms and the number of finger locking episodes per day.

    - Time 1: Baseline or Day 1 - Time 2: After treatments in 4 weeks - Time 3: 1 month after finishing treatments in 4 weeks.

  • Disability of the arm, shoulder and hand

    This is a questionnaire designed to assess the level of upper extremity impairment. It evaluates the functional ability of the wrist and finger joints, comprising 30 questions related to the patient's daily life activities and work capacity.

    - Time 1: Baseline or Day 1 - Time 2: After treatments in 4 weeks - Time 3: 1 month after finishing treatments in 4 weeks.

Study Arms (2)

ultrasound therapy combined with cassava wax hot immersion

EXPERIMENTAL

ultrasound therapy combined with cassava wax hot immersion group and ultrasound therapy only

Device: ultrasound therapy and cassava wax hot immersion

ultrasound therapy

SHAM COMPARATOR

ultrasound therapy

Device: ultrasound therapy

Interventions

participants sat in a comfortable position with their hand placed on a pillow or cushion. Ultrasound gel was applied to the base of the painful finger, and ultrasound therapy was performed for 5 minutes at a frequency of 3 MHz and an intensity of 0.5-1 W/cm. Afterward, the hand was cleaned and immersed in cassava wax heated to 125°F (51.7°C). The affected hand was dipped into the wax for 3 seconds, then removed. This process was repeated for 10 cycles. The hand was then wrapped in a plastic bag and a towel for 15 minutes before the wax was removed and peeled off.

ultrasound therapy combined with cassava wax hot immersion

1\. ultrasound therapy Ultrasound gel was applied to the base of the painful finger, and ultrasound therapy was performed for 5 minutes at a frequency of 3 MHz and an intensity of 0.5-1 W/cm.

ultrasound therapy

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a diagnosis of trigger finger by a physician or a specialized physical therapist
  • Present with all of the following symptoms: pain at the base of the affected finger, triggering (catching/locking) as a primary symptom (though pain often increased with it), and a palpable or audible triggering sensation during finger flexion and extension.
  • Able to understand and follow the research procedures.

You may not qualify if:

  • Having a history of neurological conditions, such as stroke or diseases causing sensory impairment in the upper limbs.
  • Having arthritis or infection in the upper limbs
  • Having Rheumatoid Arthritis.
  • Having a skin condition in the wrist or hand area, upper limb fractures within the last 6 months, or those affecting movement.
  • Having musculoskeletal deformities of the upper limbs that impact movement.
  • Having an inflammation (e.g., pain, swelling, redness, warmth) in the wrist and fingers
  • Having a history of upper limb surgery, an allergy to cassava starch/flour.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Narongsak Khamnon

Chiang Rai, Tha Sut, 57100, Thailand

Location

MeSH Terms

Interventions

Ultrasonic Therapy

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Arm 1: Name: Cassava waxes hot bath group ( Experimental group) Type: Experimental Description: Ultrasound therapy combined with cassava wax hot immersion Arm 2: Name: Control or comparison group Type: Active Comparator (Control) Description: Ultrasound therapy only
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Physical Therapy, School of Allied Health Sciences

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 17, 2025

Study Start

September 1, 2025

Primary Completion

September 30, 2025

Study Completion

October 30, 2025

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations