Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis

Thumb Osteoarthritis Clinical Trial

Official title:

Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05315297
• Other study ID #: 64143
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Long-Term Objective: Determine if high-frequency PEMF therapy reduces pain in patients with thumb carpometacarpal (CMC) joint osteoarthritis (OA).

Study Design and Methods: This will be a randomized controlled pilot study with 60 subjects with CMC OA randomly divided in two groups. Thirty subjects will receive high-frequency PEMF therapy overlying the CMC joint overnight daily for four weeks. The other 30 subjects will receive a sham PEMF therapy device applied to the same joint overnight daily for four weeks. Pain and function questionnaires will be obtained for all patients at enrollment, four weeks, and six weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• an existing diagnosis of CMC OA by a hand specialist based on clinically (tenderness to palpation at the CMC joint and/or positive CMC grind test) and/or radiographically identified CMC OA

• reported pain intensity during activities of daily living less than 7 on the Numeric Pain Rating Scale (NPRS)

Exclusion Criteria:

• pregnant

• unable to consent

• with current infection in hand or upper extremity

• have had prior fracture, significant hand injury, tenosynovitis, complex regional pain syndrome, and/or Dupuytren's disease affecting the thumb

• history of surgical or procedural intervention for CMC OA in the hand of study interest

• do not speak English

• have hand or wrist implants

• have heart or brain implants

Related Conditions & MeSH terms

• Arthritis
• Osteoarthritis
• Thumb Osteoarthritis

Intervention

Device:
• PEMF device
PEMF device wear overnight daily for four weeks
• Sham PEMF device
Sham PEMF device wear overnight daily for four weeks. Sham PEMF devices do not emit a radiofrequency electromagnetic field but are otherwise identical in appearance to the PEMF device

Locations

Country	Name	City	State
United States	Stanford Medicine Outpatient Center	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale (NPRS)	NPRS is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	4 weeks
Secondary	Numeric Pain Rating Scale (NPRS)	NPRS is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	6 weeks
Secondary	Patient-Rated Wrist/Hand Evaluation (PRWHE)	PRWHE consists of 15 questions on symptoms with daily activities scored on a 11-point numeric scale, in which '0' represents no difficulty or pain. The total score is then scaled from '0' representing no disability to '100' representing most severe disability.	4 and 6 weeks
Secondary	Single Assessment Numeric Evaluation (SANE)	SANE is a single-question outcome measure that asks patient to rate their function of the treated area on a scale from '0' to '100' ("For the problem that you are seeking treatment for today, out of 100% (100% being normal), how would you rate the function of your RIGHT/LEFT thumb today?").	4 and 6 weeks