Efficacy of Acupuncture in Patients With Lower Extremity Amputation With Neuroma

NCT ID: NCT05244369

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-07-01

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.

Detailed Description

The study was designed as a prospective, randomized, controlled trial. Thirty six people who met the inclusion criteria will randomized into two groups of 18 people. The first group will be designated as acupuncture therapy group and patients in the second group will be designated as the control group. Patients will be evaluated with visuel analog scale (10cm-VAS), LANSS (Self-Leeds Assessment of Neuropathic Symptoms and Sign) scale, Locomotor Capacity Index, 2-minute walking test, USG measurement. The patients will be evaluated at the beginning of the treatment (0.month), the end of the treatment (1st month), and the 4th month.

Conditions

Neuroma Amputation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acupuncture+TENS group

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.

Group Type: ACTIVE_COMPARATOR

Acupuncture+TENS

Intervention Type: 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.

Only TENS group

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.

Group Type: OTHER

Only TENS

Intervention Type: 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

Interventions

Only TENS

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

Intervention Type: OTHER

Acupuncture+TENS

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yasin Demir

Physical Medicine and Rehabilitation Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma Özcan, MD

Role: PRINCIPAL_INVESTIGATOR

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Locations

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

18

Identifier Type: -

Identifier Source: org_study_id