Traumatic Brain InjuryNCT05460728
Dry Needling Effects Post-traumatic Brain Injury
A study testing Dry needling in people with Traumatic Brain Injury, run by Anas Radi Hassan Alashram at 1 site in Jordan.
Trial summary
Thirty-six years old male with a history of TBI with compromised functionality of the right upper and lower limbs, spasticity, distributed balance, and difficulties performing independent gait has participated in the study. Read more about this study
- Who is it for?
- Ages 30 to 40 years, men only
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteJordan
- Study dates
- 5 Apr 2022to 9 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 30 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Traumatic brain injury
Who cannot join
- Unstable status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dry Needling Effects on Spasticity and General Functioning in Patients With Traumatic Brain Injury: A Case Study
Thirty-six years old male with a history of TBI with compromised functionality of the right upper and lower limbs, spasticity, distributed balance, and difficulties performing independent gait has participated in the study. Berg balance scale, 6-minute walk test, modified Ashworth scale, and functional independence measure was used to assess balance, gait, spasticity, and functional intemperance, respectively.
Read the detailed description
A 36-year-old man (height: 1.75 m, weight: 73 kg) with a 6-month history of TBI due to a motor vehicle accident resulting in right hemiplegia was admitted in March 2022 to the outpatient Neurological Physiotherapy Clinic. He was alert and oriented and had expressive aphasia. The patient had compromised functionality of the right upper and lower limbs, spasticity, distributed balance, and difficulties performing independent gait. He was right-hand dominant.
Demographic data were recorded including age, gender, occupation, and duration of disease. The outcome measures were evaluated at baseline (T0), 12 weeks from T0 (T1), and 16 weeks from T0 (4 weeks after the intervention, T2).
Spasticity assessment Spasticity for the upper and lower limbs was evaluated using the modified Ashworth Scale (MAS). The scale evaluates the resistance of a limb to a rapid passive stretch in 6 scores from 0 to 5. Score 0 indicates normal muscle tone, and 5 indicates rigid limb. The MAS for a patient with TBI has shown good reliability (ICC = 0.62-0.90).
Gait and balance assessment The primary outcome of the 6-MWT was the distance covered by the patient in 6 minutes. It was used to evaluate functional capacity in individuals with chronic disorders. The 6-MWT is a good predictor of cardiorespiratory endurance in patients with TBI. The 6-MWT for a patient with TBI has shown good reliability (ICC = 0.96-0.98) and good discriminant validity. The test was applied according to the guidelines provided by of American Thoracic Society (ATS). Two reference points were placed at 30 m from each other. Before and immediately following the test, heart rate and oxygen saturation were taken using a pulse oximeter. The patient was able to complete the 6-MWT without taking a rest break. Gait speed was demonstrated in meters per minute by dividing the total distance covered in the 6-MWT by 6 minutes.
The balance and risk of falls were evaluated using Berg Balance Scale (BBS). This scale includes 14 items requiring patients to complete tasks related to the everyday life of varying difficulty levels. The total final scores range from 0 to 56. A total score of fewer than 45 exhibits balance impairment. The BBS has excellent reliability (ICC = 0.986) in patients with TBI.
Independence measure The Functional Independence Measure (FIM) is a tool that measures the individual's degree of dependency. Thirteen tasks belong to a motor and 5 to a cognitive element. Each activity is evaluated on a 7-point scale ranging from 1 (complete dependency) to 7 (complete autonomy). A total scores range from 18 to 126, corresponding to 13-91 for the motor subscore and 5-35 for the cognitive sub-score.
Intervention The intervention was performed in an outpatient Neurological Physiotherapy Clinic, Amman, Jordan, by a skilled physical therapist. The MTrPs were detected in the upper and lower limbs based on the DNT criteria for spasticity: 1) Fundamental criteria: Limitation to passive stretching or activating of myotatic reflex and tight muscle band, and 2) Affirmative criteria: visual or tactile identification of global or focal twitch response when inserting the needle, and neural release (i.e. immediate release from contraction).
A three-weekly session of DNT was administered with an acupuncture needle (0.30 × 50 mm; Huan Qiu, Suzhou, China). For each session, DNT was applied in the deltoid, biceps brachialis, wrist extensors and flexors, thenar muscles, vastus medialis, gastrocnemius medialis, and tibialis anterior. Following focal twitch responses (maximum three), the dry needle was left inserted for 15 minutes in each muscle.
- Conditions
- Traumatic Brain Injury
- Being tested
- Dry needling
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
A three-weekly session of DNT was administered with an acupuncture needle (0.30 × 50 mm; Huan Qiu, Suzhou, China). For each session, DNT was applied in the deltoid, biceps brachialis, wrist extensors and flexors, thenar muscles, vastus medialis, gastrocnemius medialis, and tibialis anterior (Hong, 1994). Following focal twitch responses (maximum three), the dry needle was left inserted for 15 minutes in each muscle.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Not described Receives: Other: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Ashworth Scale (MAS)
Spasticity for the upper and lower limbs was evaluated using the modified Ashworth Scale (MAS) (Ghotbi, 2009). The scale evaluates the resistance of a limb to a rapid passive stretch in 6 scores from 0 to 5. Score 0 indicates normal muscle tone, and 5 indicates rigid limb (Bohannon, 1987). The MAS for a patient with TBI has shown good reliability (ICC = 0.62-0.90) (Mehrholz, 2005).
Measured: Change from baseline MAS at 12-week and 16-week
Secondary outcomes (3)
6-Minute Walk Teat (6-MWT)
The 6-Minute Walk Teat (6-MWT) was the distance covered by the patient in 6 minutes. It was used to evaluate functional capacity in individuals with chronic disorders (Danielsson, 2007). The 6-MWT is a good predictor of cardiorespiratory endurance in patients with TBI (Mossberg, 2012). The 6-MWT for a patient with TBI has shown good reliability (ICC = 0.96-0.98) and good discriminant validity (Bartels, 2012). The test was applied according to the guidelines provided by of American Thoracic Society (ATS) (ATS Statement,2002). Two reference points were placed at 30 m from each other. Before and immediately following the test, heart rate and oxygen saturation were taken using a pulse oximeter. The patient was able to complete the 6-MWT without taking a rest break. Gait speed was demonstrated in meters per minute by dividing the total distance covered in the 6-MWT by 6 minutes.
Measured: Change from baseline 6-MWT at 12-week and 16-week
Berg Balance Scale (BBS)
The balance and risk of falls were evaluated using Berg Balance Scale (BBS). This scale includes 14 items requiring patients to complete tasks related to the everyday life of varying difficulty levels. The total final scores range from 0 to 56. A total score of fewer than 45 exhibits balance impairment (Berg,1989; Zwick,2000). The BBS has excellent reliability (ICC = 0.986) in patients with TBI (Newstead,2005).
Measured: Change from baseline BBS at 12-week and 16-week
Functional Independence Measure (FIM)
The Functional Independence Measure (FIM) is a tool that measures the individual's degree of dependency. Thirteen tasks belong to a motor and 5 to a cognitive element. Each activity is evaluated on a 7-point scale ranging from 1 (complete dependency) to 7 (complete autonomy). A total scores range from 18 to 126, corresponding to 13-91 for the motor subscore and 5-35 for the cognitive sub-score (Hamilton, 1987).
Measured: Change from baseline FIM at 12-week and 16-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start5 Apr 2022
- Primary completion8 Jul 2022
- Study completion9 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anas Radi Hassan Alashram
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anas Radi Hassan Alashram, Middle East University
- Investigators
- ANAS RADI H Annino, Study director, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460728
- Sponsor's protocol ID
- SREC/22/05/041
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alashram AR. Dry needling effects on motor impairments in a patient with traumatic brain injury: A case study. J Bodyw Mov Ther. 2024 Jul;39:214-217. doi: 10.1016/j.jbmt.2024.03.011. Epub 2024 Mar 7.
PubMed 38876628
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling Effects on Spasticity and General Functioning in Patients With Traumatic Brain Injury: A Case Study
- ClinicalTrials.gov ID
- NCT05460728
- Acronym / sponsor ID
- SREC/22/05/041
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Anas Radi Hassan AlashramUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 9 Jul 2022 (actual)
- First posted
- 15 Jul 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.
Thirty-six years old male with a history of TBI with compromised functionality of the right upper and lower limbs, spasticity, distributed balance, and difficulties performing independent gait has participated in the study. Berg balance scale, 6-minute walk test, modified Ashworth scale, and functional independence measure was used to assess balance, gait, spasticity, and functional intemperance, respectively.
Detailed description
A 36-year-old man (height: 1.75 m, weight: 73 kg) with a 6-month history of TBI due to a motor vehicle accident resulting in right hemiplegia was admitted in March 2022 to the outpatient Neurological Physiotherapy Clinic. He was alert and oriented and had expressive aphasia. The patient had compromised functionality of the right upper and lower limbs, spasticity, distributed balance, and difficulties performing independent gait. He was right-hand dominant.
Demographic data were recorded including age, gender, occupation, and duration of disease. The outcome measures were evaluated at baseline (T0), 12 weeks from T0 (T1), and 16 weeks from T0 (4 weeks after the intervention, T2).
Spasticity assessment Spasticity for the upper and lower limbs was evaluated using the modified Ashworth Scale (MAS). The scale evaluates the resistance of a limb to a rapid passive stretch in 6 scores from 0 to 5. Score 0 indicates normal muscle tone, and 5 indicates rigid limb. The MAS for a patient with TBI has shown good reliability (ICC = 0.62-0.90).
Gait and balance assessment The primary outcome of the 6-MWT was the distance covered by the patient in 6 minutes. It was used to evaluate functional capacity in individuals with chronic disorders. The 6-MWT is a good predictor of cardiorespiratory endurance in patients with TBI. The 6-MWT for a patient with TBI has shown good reliability (ICC = 0.96-0.98) and good discriminant validity. The test was applied according to the guidelines provided by of American Thoracic Society (ATS). Two reference points were placed at 30 m from each other. Before and immediately following the test, heart rate and oxygen saturation were taken using a pulse oximeter. The patient was able to complete the 6-MWT without taking a rest break. Gait speed was demonstrated in meters per minute by dividing the total distance covered in the 6-MWT by 6 minutes.
The balance and risk of falls were evaluated using Berg Balance Scale (BBS). This scale includes 14 items requiring patients to complete tasks related to the everyday life of varying difficulty levels. The total final scores range from 0 to 56. A total score of fewer than 45 exhibits balance impairment. The BBS has excellent reliability (ICC = 0.986) in patients with TBI.
Independence measure The Functional Independence Measure (FIM) is a tool that measures the individual's degree of dependency. Thirteen tasks belong to a motor and 5 to a cognitive element. Each activity is evaluated on a 7-point scale ranging from 1 (complete dependency) to 7 (complete autonomy). A total scores range from 18 to 126, corresponding to 13-91 for the motor subscore and 5-35 for the cognitive sub-score.
Intervention The intervention was performed in an outpatient Neurological Physiotherapy Clinic, Amman, Jordan, by a skilled physical therapist. The MTrPs were detected in the upper and lower limbs based on the DNT criteria for spasticity: 1) Fundamental criteria: Limitation to passive stretching or activating of myotatic reflex and tight muscle band, and 2) Affirmative criteria: visual or tactile identification of global or focal twitch response when inserting the needle, and neural release (i.e. immediate release from contraction).
A three-weekly session of DNT was administered with an acupuncture needle (0.30 × 50 mm; Huan Qiu, Suzhou, China). For each session, DNT was applied in the deltoid, biceps brachialis, wrist extensors and flexors, thenar muscles, vastus medialis, gastrocnemius medialis, and tibialis anterior. Following focal twitch responses (maximum three), the dry needle was left inserted for 15 minutes in each muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry needling |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Traumatic brain injury
Key exclusion criteria (1 listed)
- Unstable status
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 |
|---|---|---|
| Dry needlingA three-weekly session of DNT was administered with an acupuncture needle (0.30 × 50 mm; Huan Qiu, Suzhou, China). For each session, DNT was applied in the deltoid, biceps brachialis, wrist extensors and flexors, thenar muscles, vastus medialis, gastrocnemius medialis, and tibialis anterior (Hong, 1994). Following focal twitch responses (maximum three), the dry needle was left inserted for 15 minutes in each muscle. | Other | Dry needling |
Primary outcome
modified Ashworth Scale (MAS)
Time frame: Change from baseline MAS at 12-week and 16-week
Spasticity for the upper and lower limbs was evaluated using the modified Ashworth Scale (MAS) (Ghotbi, 2009). The scale evaluates the resistance of a limb to a rapid passive stretch in 6 scores from 0 to 5. Score 0 indicates normal muscle tone, and 5 indicates rigid limb (Bohannon, 1987). The MAS for a patient with TBI has shown good reliability (ICC = 0.62-0.90) (Mehrholz, 2005).
3 secondary outcomes
6-Minute Walk Teat (6-MWT)
Time frame: Change from baseline 6-MWT at 12-week and 16-week
Berg Balance Scale (BBS)
Time frame: Change from baseline BBS at 12-week and 16-week
Functional Independence Measure (FIM)
Time frame: Change from baseline FIM at 12-week and 16-week
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 15 Jul 2022.
- Derived from this study: PubMed 38876628Alashram AR. Dry needling effects on motor impairments in a patient with traumatic brain injury: A case study. J Bodyw Mov Ther. 2024 Jul;39:214-217. doi: 10.1016/j.jbmt.2024.03.011. Epub 2024 Mar 7.
- Individual participant dataSharing planned: No
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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.
ANAS RADI H Annino study director
University of Rome Tor Vergata
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling in people with Traumatic Brain Injury, run by Anas Radi Hassan Alashram at 1 site in Jordan.
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 1 inclusion and 1 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 15 Jul 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 Jordan. 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?
modified Ashworth Scale (MAS) (time frame: Change from baseline MAS at 12-week and 16-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05460728, which also lists 1 linked publication.
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 15 Jul 2022.