Efficacy of Acupuncture in Patients With Lower Extremity Amputation With Neuroma

NCT05244369 | Completed

• 1 other identifier: 18
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Neuroma often occurs after major nerve damage or transection and can be diagnosed with pain at the tip of the stump, positive tinel, imaging (USG/MR). Various treatment methods are used for neuropathic pain, including pharmacological agents, intralesional steroid and local anesthetic injection, alcohol, phenol, radiofrequency or cryotherapy, ablation and surgical applications. Exercise (ROM and relaxation), TENS, biofeedback, hypnosis, acupuncture, psychotherapy, mirror therapy can be used in the treatment of neuropathic pain in amputees. In this study, the investigators aimed to examine the effectiveness of acupuncture on pain, neuroma size and functional status in individuals with lower extremity amputation with neuroma.

Conditions

Neuroma Amputation

Keywords

Lower Extremity Amputation with Neuroma; Acupuncture

Outcome Measures

Primary Outcomes (5)

• LANSS (Self-Leeds Assessment of Neuropathic Symptoms and Sign)

  The LANSS scale consists of two parts. If the score is 12 and above, it will be classified as neuropathic, and if it is below 12, it will be classified as nociceptive pain

  baseline, change from baseline VAS at 4 and 16 weeks

• Locomotor Capacity Index

  the patient's ability to perform 14 activities with the prosthesis will be evaluated. The total maximum score is 42, and the higher the total score, the higher the locomotor capacity.

  baseline, change from baseline VAS at 4 and 16 weeks

• 10-point VAS

  The overall prosthesis satisfaction and socket comfort of the patients will be evaluated with a 10-point VAS. Patients will be asked to rate their condition from 0 (none) to 10 (maximum).

  baseline, change from baseline VAS at 4 and 16 weeks

• 2-minute walking test

  the distance he walked at the end of two minutes will be recorded in meters (m).

  baseline, change from baseline VAS at 4 and 16 weeks

• ultrasonographic measurement

  The size of the neuroma will be visualized with a 7.5-12 MHz linear transducer (LOGIQ 7 Pro; GE Yokogawa medical system, Tokyo, Japan) USG and measured by the same clinician

  baseline, change from baseline VAS at 4 and 16 weeks

Study Arms (2)

Acupuncture+TENS group

ACTIVE COMPARATOR

Acupuncture application twice a week - a total of 8 sessions, and rehabilitation program consisting of joint range of motion, stretching and strengthening exercises for 30 minutes for 5 days a week for 4 weeks, current frequency 60-100 Hz to stump tip, impulse duration 100 microseconds transcutaneous electrical nerve stimulation (TENS) will be applied.

Procedure: Acupuncture+TENS

Only TENS group

OTHER

A rehabilitation program consisting of joint range of motion, stretching, and strengthening exercises for 30 minutes, 5 days a week for only 4 weeks, and transcutaneous electrical nerve stimulation (TENS) with a current frequency of 60-100 Hz and an impulse duration of 100 microseconds will be applied.

Other: Only TENS

Interventions

Only TENS OTHER

Rehabilitation program consisting of joint range of motion, stretching and strengthening exercises for 30 minutes, 5 days a week for only 4 weeks, and application of transcutaneous electrical nerve stimulation (TENS) to the tip of the stump

Only TENS group

Acupuncture+TENS PROCEDURE

acupuncture application twice a week - a total of 8 sessions, rehabilitation program consisting of exercises 5 days a week for 4 weeks and transcutaneous electrical nerve stimulation (TENS) to the stump tip.

Acupuncture+TENS group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Having a diagnosis of lower extremity amputation
• Consent to be included in the study
• Having a complaint of pain

You may not qualify if:

• Conditions in which acupuncture is strictly contraindicated (inflamed, infected or impaired skin, spontaneous bleeding, metal allergy, fear of needles, unstable diabetes mellitus patients, history of unstable epilepsy or unexplained convulsions, unstable acute cardiac arrhythmia or heart failure , heart valve disease or history of replacement surgery, presence of lymphedema)
• Lack of consent to be included in the study
• There are situations where TENS application is inconvenient
• There are situations where TENS application is inconvenient
• Lack of consent to be included in the study

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

Study Officials

• Fatma Özcan, MD

  Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: March 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 30, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)