PainNCT03170557
Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation
A study testing Traditional chinese acupuncture and Aspecific needle skin stimulation in people with Pain and Spinal Cord Injuries, run by Montecatone Rehabilitation Institute S.p.A. at 1 site in Italy.
Trial summary
Pain is one of the most common problems in patients with spinal cord injury (SCI) and persistent pain (that can be of different origin: nociceptive, neuropathic or mixed) is often poorly responsive to pharmacological therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Spinal Cord Injuries
- What is being tested?
- Traditional chinese acupuncture and Aspecific needle skin stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 25 Sep 2017to 25 Feb 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent pain: NRS score >2 in at least 5 assessments in 5 consecutive days, despite usual antalgic management;
- Spinal cord injury due to any etiology (both traumatic and non-traumatic);
- Spinal cord injury of any neurological level, complete or incomplete, classifiable as Asia Impairment Score (AIS) A, B, C or D;
- Stable medical conditions;
- At least 1 month away from the spinal cord injury event.
Who cannot join
- Sporadic pain;
- Mechanical ventilation;
- Pregnancy;
- Disorders of consciousness;
- Incapacity to give informed consent in person.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Comparative Trial to Assess the Efficacy of Traditional Acupuncture vs Aspecific Needle Skin Stimulation for Persistent Pain in Subjects With Spinal Cord Injury
Pain is one of the most common problems in patients with spinal cord injury (SCI) and persistent pain (that can be of different origin: nociceptive, neuropathic or mixed) is often poorly responsive to pharmacological therapy. Attention has been paid to the use of non-pharmacological therapies and interventional techniques in treating pain in other clinical conditions, and acupuncture has been the treatment most used and appreciated for its effectiveness. However, only few studies are available on the use of acupuncture in SCI patients. The present randomized, comparative trial aims to clarify the efficacy of traditional acupuncture vs. aspecific needle skin stimulation in treating persistent pain in subjects with spinal cord injury, by overcoming the biases reported in previous studies.
Read the detailed description
About 67% of patients with spinal cord injury (SCI) experience painful symptoms in the course of life after injury and a third evaluates the pain as "severe", with a significant impact on quality of life, due to limitations in daily activities and autonomy. Persistent pain can be of different origin and may be nociceptive, neuropathic or mixed. However, it is often poorly responsive to pharmacological therapy. For some years, attention has been paid to the use of non-pharmacological therapies and interventional techniques in treating pain, and acupuncture has been the treatment most used and appreciated for its effectiveness. Only two studies on the use of acupuncture in SCI patients were included in the only Cochrane review available, dated 2014. Such studies, focusing on the painful shoulder syndrome and, therefore, on skeletal muscle pain, show a "non-superiority" of acupuncture compared to sham acupuncture treatment or Trager approach. However, the review does not come to any clear conclusions on the effectiveness of intervention because of the small number of cases and high risk of bias.
A more recent primary, randomized, controlled trial on SCI patients, although focusing on chronic pain and on a single acupuncture technique, uses a questionable study design (cross-over) to demonstrate treatment efficacy.
The present randomized, comparative trial aims to clarify the efficacy of traditional acupuncture vs. aspecific needle skin stimulation in treating persistent pain in subjects with spinal cord injury, by overcoming the biases reported in previous studies. Because of the intrinsic effects of sham acupuncture and, generally, of skin stimulation, a statistically significant change in the Numerical Rating Scale (NRS) measurements is expected even in the comparison group. To minimize this bias, which cannot be avoided, and to maintain the blindness of the patient as much as possible, the comparison group is treated by the insertion of needles in skin areas outside the metamer(s) affected by pain.
Primary objective:
- To evaluate the efficacy of traditional acupuncture vs. aspecific needle skin stimulation for persistent pain in subjects with spinal cord injury, at the end of treatment and at the 3 week follow-up.
Secondary objectives:
- Reduction of drug intake, at the end of treatment and at the subsequent follow-up;
- Reduction of anxiety/depression, at the end of treatment and at the subsequent follow-up;
- Improvement of quality of life, at the end of treatment and at the subsequent follow-up;
- Persistence of the effect of acupuncture 9 weeks after treatment.
Data concerning any adverse events, related to both experimental treatments of the trial, will also be collected.
- Conditions
- Pain, Spinal Cord Injuries
- Being tested
- Traditional chinese acupuncture, Aspecific needle skin stimulation
- Keywords
- Persistent pain, Spinal cord injury, Acupuncture, Randomized Controlled Trial, RCT
- Medical subject headings
- Pain, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional chinese acupunctureOther
Traditional chinese acupuncture (somatopuncture points, auriculotherapy points, craniopuncture and wrist-ankle acupuncture). Simultaneously, the usual pharmacological treatment for pain is maintained, based on clinical needs.
Aspecific needle skin stimulationOther
Superficial needling of needles in skin areas outside the pain affected dermatome(s). Simultaneously, the usual pharmacological treatment for pain is maintained, based on clinical needs.
| Study group | Role | What they receive |
|---|---|---|
| Traditional chinese acupuncture | Active comparator | Traditional chinese acupuncture. Administration of 12 sessions (2 per week for 6 weeks). Each session lasts 20-30 minutes. Receives: Other: Traditional chinese acupuncture |
| Aspecific needle skin stimulation | Sham comparator | Aspecific needle skin stimulation. Administration of 12 sessions (2 per week for 6 weeks). Each session lasts 20-30 minutes. Receives: Other: Aspecific needle skin stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Pain reduction of at least 2 points on the NRS scale
Measured: Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)
Secondary outcomes (5)
Persistence of pain reduction in Acupuncture arm
Pain reduction of at least 2 points on the NRS scale
Measured: Follow-up 2 (9 weeks after closing session 12)
Reduction of drugs intake
Intake reduction of antalgic, hypnotic and anxiolytic drugs (number and dosage)
Measured: Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12); follow-up 2 (9 weeks after closing session 12)
Reduction of Anxiety/Depression
Reduction of anxiety/depression symptoms, assessed by Hospital Anxiety and Depression Scale
Measured: Baseline (initial visit); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12); follow-up 2 (9 weeks after closing session 12)
Reduction of pain interference on sleep and quality of life
Reduction of pain interference on sleep and quality of life, assessed by Multidimensional Pain Inventory scale, Part 1
Measured: Baseline (initial visit); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)
Improvement of quality of life
Increase of participation in family and social life, assessed by Multidimensional Pain Inventory scale, Part 2
Measured: Baseline (initial visit); closing session 12 (6 weeks); follow-up 2 (9 weeks after closing session 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start25 Sep 2017
- Primary completion25 Jan 2019
- Study completion25 Feb 2019
Why it stopped: After a first stop due to acupuncturists unavailability, the Covid-19 pandemic also impacted on the study time schedule for acupuncture administration and outcomes evaluation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized comparative trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montecatone Rehabilitation Institute S.p.A.
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Medici Agopuntori Bolognesi (A.M.A.B.)
- Responsible party
- Sponsor
- Investigators
- Angela Morreale, MD, Principal investigator, Montecatone Rehabilitation Institute S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170557
- Sponsor's protocol ID
- CE-17017
- Status last verified
- Aug 2022
- First submitted
- 26 May 2017
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Comparative Trial to Assess the Efficacy of Traditional Acupuncture vs Aspecific Needle Skin Stimulation for Persistent Pain in Subjects With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03170557
- Acronym / sponsor ID
- CE-17017
- Conditions
- Pain, Spinal Cord Injuries
- Keywords
- Persistent pain, Spinal cord injury, Acupuncture, Randomized Controlled Trial, RCT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After a first stop due to acupuncturists unavailability, the Covid-19 pandemic also impacted on the study time schedule for acupuncture administration and outcomes evaluation.
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Montecatone Rehabilitation Institute S.p.A.University, hospital or other
- Collaborators
- Associazione Medici Agopuntori Bolognesi (A.M.A.B.)
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 31 May 2017 (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.
Pain is one of the most common problems in patients with spinal cord injury (SCI) and persistent pain (that can be of different origin: nociceptive, neuropathic or mixed) is often poorly responsive to pharmacological therapy. Attention has been paid to the use of non-pharmacological therapies and interventional techniques in treating pain in other clinical conditions, and acupuncture has been the treatment most used and appreciated for its effectiveness. However, only few studies are available on the use of acupuncture in SCI patients. The present randomized, comparative trial aims to clarify the efficacy of traditional acupuncture vs. aspecific needle skin stimulation in treating persistent pain in subjects with spinal cord injury, by overcoming the biases reported in previous studies.
Detailed description
About 67% of patients with spinal cord injury (SCI) experience painful symptoms in the course of life after injury and a third evaluates the pain as "severe", with a significant impact on quality of life, due to limitations in daily activities and autonomy. Persistent pain can be of different origin and may be nociceptive, neuropathic or mixed. However, it is often poorly responsive to pharmacological therapy. For some years, attention has been paid to the use of non-pharmacological therapies and interventional techniques in treating pain, and acupuncture has been the treatment most used and appreciated for its effectiveness. Only two studies on the use of acupuncture in SCI patients were included in the only Cochrane review available, dated 2014. Such studies, focusing on the painful shoulder syndrome and, therefore, on skeletal muscle pain, show a "non-superiority" of acupuncture compared to sham acupuncture treatment or Trager approach. However, the review does not come to any clear conclusions on the effectiveness of intervention because of the small number of cases and high risk of bias.
A more recent primary, randomized, controlled trial on SCI patients, although focusing on chronic pain and on a single acupuncture technique, uses a questionable study design (cross-over) to demonstrate treatment efficacy.
The present randomized, comparative trial aims to clarify the efficacy of traditional acupuncture vs. aspecific needle skin stimulation in treating persistent pain in subjects with spinal cord injury, by overcoming the biases reported in previous studies. Because of the intrinsic effects of sham acupuncture and, generally, of skin stimulation, a statistically significant change in the Numerical Rating Scale (NRS) measurements is expected even in the comparison group. To minimize this bias, which cannot be avoided, and to maintain the blindness of the patient as much as possible, the comparison group is treated by the insertion of needles in skin areas outside the metamer(s) affected by pain.
Primary objective:
- To evaluate the efficacy of traditional acupuncture vs. aspecific needle skin stimulation for persistent pain in subjects with spinal cord injury, at the end of treatment and at the 3 week follow-up.
Secondary objectives:
- Reduction of drug intake, at the end of treatment and at the subsequent follow-up;
- Reduction of anxiety/depression, at the end of treatment and at the subsequent follow-up;
- Improvement of quality of life, at the end of treatment and at the subsequent follow-up;
- Persistence of the effect of acupuncture 9 weeks after treatment.
Data concerning any adverse events, related to both experimental treatments of the trial, will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized comparative trial
| Arm | Type | Receives |
|---|---|---|
| Traditional chinese acupuncture | Active comparator | Other: Traditional chinese acupunctureTraditional chinese acupuncture. Administration of 12 sessions (2 per week for 6 weeks). Each session lasts 20-30 minutes. |
| Aspecific needle skin stimulation | Sham comparator | Other: Aspecific needle skin stimulationAspecific needle skin stimulation. Administration of 12 sessions (2 per week for 6 weeks). Each session lasts 20-30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Persistent pain: NRS score >2 in at least 5 assessments in 5 consecutive days, despite usual antalgic management;
- Spinal cord injury due to any etiology (both traumatic and non-traumatic);
- Spinal cord injury of any neurological level, complete or incomplete, classifiable as Asia Impairment Score (AIS) A, B, C or D;
- Stable medical conditions;
- At least 1 month away from the spinal cord injury event.
Key exclusion criteria (5 listed)
- Sporadic pain;
- Mechanical ventilation;
- Pregnancy;
- Disorders of consciousness;
- Incapacity to give informed consent in person.
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 |
|---|---|---|
| Traditional chinese acupunctureTraditional chinese acupuncture (somatopuncture points, auriculotherapy points, craniopuncture and wrist-ankle acupuncture). Simultaneously, the usual pharmacological treatment for pain is maintained, based on clinical needs. | Other | Traditional chinese acupuncture |
| Aspecific needle skin stimulationSuperficial needling of needles in skin areas outside the pain affected dermatome(s). Simultaneously, the usual pharmacological treatment for pain is maintained, based on clinical needs. | Other | Aspecific needle skin stimulation |
Primary outcome
Pain reduction
Time frame: Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)
Pain reduction of at least 2 points on the NRS scale
5 secondary outcomes
Persistence of pain reduction in Acupuncture arm
Time frame: Follow-up 2 (9 weeks after closing session 12)
Reduction of drugs intake
Time frame: Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12); follow-up 2 (9 weeks after closing session 12)
Reduction of Anxiety/Depression
Time frame: Baseline (initial visit); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12); follow-up 2 (9 weeks after closing session 12)
Reduction of pain interference on sleep and quality of life
Time frame: Baseline (initial visit); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)
Improvement of quality of life
Time frame: Baseline (initial visit); closing session 12 (6 weeks); follow-up 2 (9 weeks after closing session 12)
Results and safety
The study was stopped early (reason given: After a first stop due to acupuncturists unavailability, the Covid-19 pandemic also impacted on the study time schedule for acupuncture administration and outcomes evaluation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Angela Morreale, MD principal investigator
Montecatone Rehabilitation Institute S.p.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional chinese acupuncture and Aspecific needle skin stimulation in people with Pain and Spinal Cord Injuries, run by Montecatone Rehabilitation Institute S.p.A. at 1 site in Italy.
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 5 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: stopped early, as of the sponsor's last update on 23 Aug 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 Italy. 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.
Are results available for this study?
The study was stopped early (reason given: After a first stop due to acupuncturists unavailability, the Covid-19 pandemic also impacted on the study time schedule for acupuncture administration and outcomes evaluation.). 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?
Pain reduction (time frame: Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)). 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 23 Aug 2022.