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Efficacy of Acupuncture in Patients With Lower Extremity Amputation With Neuroma

Primary Purpose

Neuroma Amputation

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Only TENS

Acupuncture+TENS

About this trial

This is an interventional treatment trial for Neuroma Amputation focused on measuring Lower Extremity Amputation with Neuroma, Acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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:

Exclusion Criteria for the Acupuncture+TENS group

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

Exclusion Criteria for only TENS group

There are situations where TENS application is inconvenient
Lack of consent to be included in the study

Sites / Locations

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Acupuncture+TENS group

Only TENS group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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.

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).

2-minute walking test

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05244369

First Posted

February 8, 2022

Last Updated

September 29, 2022

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05244369

Brief Title

Efficacy of Acupuncture in Patients With Lower Extremity Amputation With Neuroma

Official Title

Efficacy of Acupuncture in Patients With Lower Extremity Amputation With Neuroma: A Prospective Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

March 1, 2022 (Actual)

Primary Completion Date

July 1, 2022 (Actual)

Study Completion Date

July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroma Amputation

Keywords

Lower Extremity Amputation with Neuroma, Acupuncture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture+TENS group

Arm Type

Active Comparator

Arm Description

Arm Title

Only TENS group

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Only TENS

Intervention Description

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

Procedure

Intervention Name(s)

Acupuncture+TENS

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame