Phantom Limb PainPhase 3NCT00460161
Acupuncture for Phantom Limb Pain
A Phase 3 study testing acupuncture in people with Phantom Limb Pain, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Phantom pain is a common complication following limb amputation, and is thought to result from a system of pathophysiological mechanisms - peripheral, spinal, central and psychological. Treatment is primarily medical, using antidepressant and anticonvulsant medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2009to Aug 2009
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either gender
- Age 18 years and older
- Scheduled for lower single limb amputation (above or below knee)
- Ability to comply with study protocol
Who cannot join
- Patients requiring limb amputation due to trauma
- Patients displaying symptoms of overt Axis-1 psychopathology such as Schizophrenia or Substance Abuse
- Inability to comply with the study protocol
- Previous experience with acupuncture treatment; current use of complementary or alternative medical treatments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture for Phantom Limb Pain: A Randomized, Double-Blind, Placebo/Sham - Controlled Study
Phantom pain is a common complication following limb amputation, and is thought to result from a system of pathophysiological mechanisms - peripheral, spinal, central and psychological. Treatment is primarily medical, using antidepressant and anticonvulsant medications. At present, there is no evidence-based approach for the management of phantom limb pain (PLP). Acupuncture is an ancient Chinese treatment during which thin needles (diameter 0.20-0.30mm) are inserted into various points on the skin. Studies of this treatment have found significant benefit in a number of conditions with chronic pain.
We propose a randomized, double-blind, placebo/sham -controlled study to evaluate whether acupuncture is an effective and safe modality for preventing and reducing PLP in patients following lower limb amputation. Patients requiring lower limb amputation (above-ankle) will be randomized into two groups, for real or placebo/sham acupuncture treatment. Both groups will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture treatment protocol, using either true or placebo needles at sham acupuncture points, for a period of four weeks (eight treatments).
The primary outcome to be evaluated will be PLP at 4 weeks, using a site-specific numerical rating pain scale (ss-NRS). Secondary outcome measures to be evaluated are: stump pain (ss-NRS); analgesic use (Tramadol, 100mg Tablet); and depressive symptoms, using the Beck Depression Score. Blinding of the participants will be evaluated using a Validation of Blinding Questionnaire at the end of the treatment period.
- Conditions
- Phantom Limb Pain
- Being tested
- acupuncture, placebo/sham acupuncture
- Keywords
- acupuncture, amputation, phantom limb pain
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
2 treatments/week for 4 weeks
placebo/sham acupunctureOther
2 treatments/week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | true acupuncture Receives: Procedure: acupuncture |
| 2 | Placebo comparator | placebo/sham acupuncture Receives: Other: placebo/sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation
Measured: 4 weeks
Secondary outcomes (5)
To study the effect of acupuncture on phantom limb pain at 3 months post-amputation
Measured: 3 months
To study the effect of acupuncture on stump pain at 4 weeks post-amputation
Measured: 4 weeks
To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation
Measured: 4 weeks
To study the effect of acupuncture on parameters of depression (using the Beck Depression Score) at 4 weeks and 3 months post-amputation
Measured: 4 weeks and 3 months
To study the safety of acupuncture treatment in patients following amputation with phantom limb pain
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startFeb 2009
- Primary completionAug 2009 (estimated)
Why it stopped: Lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Noah Samuels, M.D., Principal investigator, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460161
- Sponsor's protocol ID
- ACP.PLP.10.06
- Status last verified
- Aug 2008
- First submitted
- 12 Apr 2007
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Phantom Limb Pain: A Randomized, Double-Blind, Placebo/Sham - Controlled Study
- ClinicalTrials.gov ID
- NCT00460161
- Acronym / sponsor ID
- ACP.PLP.10.06
- Conditions
- Phantom Limb Pain
- Keywords
- acupuncture, amputation, phantom limb pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of patients
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (estimated)
- First posted
- 13 Apr 2007 (estimated)
- 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.
Phantom pain is a common complication following limb amputation, and is thought to result from a system of pathophysiological mechanisms - peripheral, spinal, central and psychological. Treatment is primarily medical, using antidepressant and anticonvulsant medications. At present, there is no evidence-based approach for the management of phantom limb pain (PLP). Acupuncture is an ancient Chinese treatment during which thin needles (diameter 0.20-0.30mm) are inserted into various points on the skin. Studies of this treatment have found significant benefit in a number of conditions with chronic pain.
We propose a randomized, double-blind, placebo/sham -controlled study to evaluate whether acupuncture is an effective and safe modality for preventing and reducing PLP in patients following lower limb amputation. Patients requiring lower limb amputation (above-ankle) will be randomized into two groups, for real or placebo/sham acupuncture treatment. Both groups will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture treatment protocol, using either true or placebo needles at sham acupuncture points, for a period of four weeks (eight treatments).
The primary outcome to be evaluated will be PLP at 4 weeks, using a site-specific numerical rating pain scale (ss-NRS). Secondary outcome measures to be evaluated are: stump pain (ss-NRS); analgesic use (Tramadol, 100mg Tablet); and depressive symptoms, using the Beck Depression Score. Blinding of the participants will be evaluated using a Validation of Blinding Questionnaire at the end of the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: acupuncturetrue acupuncture |
| 2 | Placebo comparator | Other: placebo/sham acupunctureplacebo/sham acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of either gender
- Age 18 years and older
- Scheduled for lower single limb amputation (above or below knee)
- Ability to comply with study protocol
Key exclusion criteria (4 listed)
- Patients requiring limb amputation due to trauma
- Patients displaying symptoms of overt Axis-1 psychopathology such as Schizophrenia or Substance Abuse
- Inability to comply with the study protocol
- Previous experience with acupuncture treatment; current use of complementary or alternative medical treatments.
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 |
|---|---|---|
| acupuncture2 treatments/week for 4 weeks | Procedure or surgery | 1 |
| placebo/sham acupuncture2 treatments/week for 4 weeks | Other | 2 |
Primary outcome
To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation
Time frame: 4 weeks
5 secondary outcomes
To study the effect of acupuncture on phantom limb pain at 3 months post-amputation
Time frame: 3 months
To study the effect of acupuncture on stump pain at 4 weeks post-amputation
Time frame: 4 weeks
To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation
Time frame: 4 weeks
To study the effect of acupuncture on parameters of depression (using the Beck Depression Score) at 4 weeks and 3 months post-amputation
Time frame: 4 weeks and 3 months
To study the safety of acupuncture treatment in patients following amputation with phantom limb pain
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
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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.
Noah Samuels, M.D. principal investigator
Shaare Zedek Medical Center, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acupuncture in people with Phantom Limb Pain, run by Shaare Zedek Medical Center at 1 site in Israel.
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 4 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: paused, as of the sponsor's last update on 18 Feb 2009. 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 Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation (time frame: 4 weeks). 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 18 Feb 2009.