Neuroma AmputationNCT05244369
Efficacy of Acupuncture in Patients With Lower Extremity Amputation With Neuroma
A study testing Only TENS and Acupuncture+TENS in people with Neuroma Amputation, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Neuroma Amputation
- What is being tested?
- Only TENS and Acupuncture+TENS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Having a diagnosis of lower extremity amputation
- Consent to be included in the study
- Having a complaint of pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara
About this study
Official title: Efficacy of Acupuncture in Patients With Lower Extremity Amputation With Neuroma: A Prospective Randomized Controlled Study
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.
Read the 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
- Being tested
- Only TENS, Acupuncture+TENS
- Keywords
- Lower Extremity Amputation with Neuroma, Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Only TENSOther
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
Acupuncture+TENSProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture+TENS group | Active comparator | 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. Receives: Procedure: Acupuncture+TENS |
| Only TENS group | Other | 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. Receives: Other: Only TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, change from baseline VAS at 4 and 16 weeks
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.
Measured: baseline, change from baseline VAS at 4 and 16 weeks
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).
Measured: baseline, change from baseline VAS at 4 and 16 weeks
2-minute walking test
the distance he walked at the end of two minutes will be recorded in meters (m).
Measured: baseline, change from baseline VAS at 4 and 16 weeks
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
Measured: baseline, change from baseline VAS at 4 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Mar 2022
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroma AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Fatma Özcan, MD, Principal investigator, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244369
- Sponsor's protocol ID
- 18
- Status last verified
- Jun 2021
- First submitted
- 8 Feb 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture in Patients With Lower Extremity Amputation With Neuroma: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05244369
- Acronym / sponsor ID
- 18
- Conditions
- Neuroma Amputation
- Keywords
- Lower Extremity Amputation with Neuroma, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture+TENS group | Active comparator | Procedure: Acupuncture+TENSAcupuncture 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. |
| Only TENS group | Other | Other: Only TENSA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Having a diagnosis of lower extremity amputation
- Consent to be included in the study
- Having a complaint of pain
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Only TENSRehabilitation 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 | Other | Only TENS group |
| Acupuncture+TENSacupuncture 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. | Procedure or surgery | Acupuncture+TENS group |
Primary outcome
LANSS (Self-Leeds Assessment of Neuropathic Symptoms and Sign)
Time frame: baseline, change from baseline VAS at 4 and 16 weeks
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
Time frame: baseline, change from baseline VAS at 4 and 16 weeks
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
Time frame: baseline, change from baseline VAS at 4 and 16 weeks
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
Time frame: baseline, change from baseline VAS at 4 and 16 weeks
the distance he walked at the end of two minutes will be recorded in meters (m).
ultrasonographic measurement
Time frame: baseline, change from baseline VAS at 4 and 16 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Neuroma Amputation
Recruiting
Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals
Amputation Neuroma, Amputation
Active, not recruiting
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
Symptomatic Neuroma, Amputation
RecruitingObservational study
Results of Nerve Surgery to Treat PostAmputation Pain
Amputation Neuroma
RecruitingPhase 2
Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap
Neuroma, Neuropathic Pain
Not yet recruiting
Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection
Pain Management, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Özcan, MD principal investigator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Only TENS and Acupuncture+TENS in people with Neuroma Amputation, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LANSS (Self-Leeds Assessment of Neuropathic Symptoms and Sign) (time frame: baseline, change from baseline VAS at 4 and 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.