CompletedNot Applicable

Efficacy of Acupuncture in Patients With Lower Extremity Amputation With Neuroma

Turkey (Türkiye)36 participantsStarted 2022-03-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: baseline, change from baseline VAS at 4 and 16 weeks

Locomotor Capacity Index

Timeframe: baseline, change from baseline VAS at 4 and 16 weeks

10-point VAS

Timeframe: baseline, change from baseline VAS at 4 and 16 weeks

2-minute walking test

Timeframe: baseline, change from baseline VAS at 4 and 16 weeks

ultrasonographic measurement

Timeframe: baseline, change from baseline VAS at 4 and 16 weeks

Trial details

NCT IDNCT05244369

SponsorGaziler Physical Medicine and Rehabilitation Education and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-01

View on ClinicalTrials.gov More Neuroma Amputation trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: baseline, change from baseline VAS at 4 and 16 weeks

Locomotor Capacity Index

Timeframe: baseline, change from baseline VAS at 4 and 16 weeks

10-point VAS

Timeframe: baseline, change from baseline VAS at 4 and 16 weeks

2-minute walking test

Timeframe: baseline, change from baseline VAS at 4 and 16 weeks

ultrasonographic measurement

Timeframe: baseline, change from baseline VAS at 4 and 16 weeks