Efficacy of Acupuncture in Patients With Lower Extremity Amputation With Neuroma

Neuroma Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05244369
• Other study ID #: 18
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: June 2021
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroma
• Neuroma Amputation

Intervention

Other:
• 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

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Gaziler Physical Medicine and Rehabilitation Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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