Clinical trial NCT05244369: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neuroma Amputation
Keywords: Lower Extremity Amputation with Neuroma
Acupuncture
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: LANSS (Self-Leeds Assessment of Neuropathic Symptoms and Sign)
timeFrame: baseline, change from baseline VAS at 4 and 16 weeks
measure: Locomotor Capacity Index
timeFrame: baseline, change from baseline VAS at 4 and 16 weeks
measure: 10-point VAS
timeFrame: baseline, change from baseline VAS at 4 and 16 weeks
measure: 2-minute walking test
timeFrame: baseline, change from baseline VAS at 4 and 16 weeks
measure: ultrasonographic measurement
timeFrame: baseline, change from baseline VAS at 4 and 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
affiliation: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Fatma Özcan, MD
role: PRINCIPAL_INVESTIGATOR
References: