PainNCT04270968
Shock Wave Therapy On Cervical Pain Following Neck Dissection Surgery
A study testing extra-corporeal shock wave therapy and topical none steroidal anti-inflammatory drug in people with Pain and Cervical Pain, run by Qassim University at 1 site in Egypt.
Trial summary
Myofascial pain syndrome (MPS) is a musculoskeletal disorder which is characterized by pain, muscle spasms and muscle tenderness, as well as a limited range of motion, weakness, and rarely, autonomous dysfunction. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Pain, Cervical Pain
- What is being tested?
- extra-corporeal shock wave therapy and topical none steroidal anti-inflammatory drug
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Nov 2018to 3 Dec 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Previous unilateral modified radical neck dissection.
- Patients with myofascial pain of upper trapezius for at least 3 months.
- Patients with palpable intramuscular taut band.
- Restriction in cervical ROM of lateral flexion and rotation.
- Provocation of the clinical symptoms by compression of the active trigger point
Who cannot join
- Patient who received medication or other therapies for MPS within the previous 2 months.
- Patients with pacemaker, pregnancy
- Open wound at the treatment area.
- Cervical myelopathy or radiculopathy, cervical spine fracture or spondylolisthesis.
- Rheumatoid arthritis.
- Coagulopathy.
- Epilepsy or any psychological disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Extracorporeal Shock Wave Therapy (ESWT) on Cervical Myofascial Pain Following Neck Dissection Surgery
Myofascial pain syndrome (MPS) is a musculoskeletal disorder which is characterized by pain, muscle spasms and muscle tenderness, as well as a limited range of motion, weakness, and rarely, autonomous dysfunction.
Read the detailed description
The occurrences of morbidity of the neck after cancer therapy were considerable and consisted of neck pain, loss of sensation, and decreased range of motion. Extracorporeal shock wave therapy (ESWT) is one of the treatment options used for patients with myofascial pain syndrome through elimination of ischemia and modulation of vasoneuroactive substance (two major causes of trigger pathophysiology) and mechanical transduction as a cellular response to external stimulation. the aim of this study was to investigate efficacy of extracorporeal shock wave therapy (ESWT) on cervical myofascial pain following neck dissection surgery.
- Conditions
- Pain, Cervical Pain
- Being tested
- extra-corporeal shock wave therapy, topical none steroidal anti-inflammatory drug
- Medical subject headings
- Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extra-corporeal shock wave therapyDevice
Also called shock wave therapy
Extracorporeal Shock Wave Therapy (ESWT) has been introduced efficiently for more than twenty years as a treatment modality in orthopedic and musculoskeletal disorders. ESWT has mechanical and cellular impacts on tissues regeneration and pain management through cavitation bubbles, acoustic micro streaming, and hyper-vascularity that can directly affect tissue calcifications, and modulate cell activity.
topical none steroidal anti-inflammatory drugDrug
Also called topical NSAID
participants received 1% topical diclofenac gel on the tender points 3 times /day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ESWT Group | Experimental | received ESWT once a week for 4 weeks (0.25 ml/mm2, 1000 shocks) plus topical none steroidal anti-inflammatory drug (NSAID; 3 times /day for 4 weeks). Receives: Device: extra-corporeal shock wave therapy |
| control group | Experimental | received only topical NSAID. Receives: Drug: topical none steroidal anti-inflammatory drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
VAS was utilized for assessing and quantifying pain exhibited by the patients through a 0-10 cm scale. Each subject was informed to mark the line according to the pain intensity experienced at that particular time where '0' means no pain and '10' means worst conceivable pain.
Measured: before treatment
Visual analogue scale
VAS was utilized for assessing and quantifying pain exhibited by the patients through a 0-10 cm scale. Each subject was informed to mark the line according to the pain intensity experienced at that particular time where '0' means no pain and '10' means worst conceivable pain.
Measured: 2 weeks of treatment
Visual analogue scale
VAS was utilized for assessing and quantifying pain exhibited by the patients through a 0-10 cm scale. Each subject was informed to mark the line according to the pain intensity experienced at that particular time where '0' means no pain and '10' means worst conceivable pain.
Measured: after 4 weeks of treatment
Secondary outcomes (3)
Cervical range of motion assessment
Cervical range of motion device (CROM; Performance Attainment Associates) was used for assessment of neck lateral flexion and rotation of both sides. The CROM instrument contains a plastic frame put on the head above the nose and ears, attached at the head back by a Velcro strap to allow precise measure, re-measure and rotational motion in an upright place to avoid individual errors. Two independent inclinometers are connected to the frame and point the head position in relation to the gravity line. Another inclinometer indicates the head position in rotation in relation to a reference position.
Measured: before treatment
Cervical range of motion assessment
Cervical range of motion device (CROM; Performance Attainment Associates) was used for assessment of neck lateral flexion and rotation of both sides. The CROM instrument contains a plastic frame put on the head above the nose and ears, attached at the head back by a Velcro strap to allow precise measure, re-measure and rotational motion in an upright place to avoid individual errors. Two independent inclinometers are connected to the frame and point the head position in relation to the gravity line. Another inclinometer indicates the head position in rotation in relation to a reference position.
Measured: 2 weeks of treatment
Cervical range of motion assessment
Cervical range of motion device (CROM; Performance Attainment Associates) was used for assessment of neck lateral flexion and rotation of both sides. The CROM instrument contains a plastic frame put on the head above the nose and ears, attached at the head back by a Velcro strap to allow precise measure, re-measure and rotational motion in an upright place to avoid individual errors. Two independent inclinometers are connected to the frame and point the head position in relation to the gravity line. Another inclinometer indicates the head position in rotation in relation to a reference position.
Measured: after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start3 Nov 2018
- Primary completion20 Nov 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Maged Basha, Qassim University
- Investigators
- MAGED A BASHA, Dr, Study director, Assistant Professor, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270968
- Sponsor's protocol ID
- 1857PT
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figure)
Publications
Guru K, Manoor UK, Supe SS. A comprehensive review of head and neck cancer rehabilitation: physical therapy perspectives. Indian J Palliat Care. 2012 May;18(2):87-97. doi: 10.4103/0973-1075.100820.
PubMed 23093823Sist T, Miner M, Lema M. Characteristics of postradical neck pain syndrome: a report of 25 cases. J Pain Symptom Manage. 1999 Aug;18(2):95-102. doi: 10.1016/s0885-3924(99)00054-8.
PubMed 10484856Bron C, Dommerholt JD. Etiology of myofascial trigger points. Curr Pain Headache Rep. 2012 Oct;16(5):439-44. doi: 10.1007/s11916-012-0289-4.
PubMed 22836591
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extracorporeal Shock Wave Therapy (ESWT) on Cervical Myofascial Pain Following Neck Dissection Surgery
- ClinicalTrials.gov ID
- NCT04270968
- Acronym / sponsor ID
- 1857PT
- Conditions
- Pain, Cervical Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 3 Nov 2018 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 17 Feb 2020 (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.
Myofascial pain syndrome (MPS) is a musculoskeletal disorder which is characterized by pain, muscle spasms and muscle tenderness, as well as a limited range of motion, weakness, and rarely, autonomous dysfunction.
Detailed description
The occurrences of morbidity of the neck after cancer therapy were considerable and consisted of neck pain, loss of sensation, and decreased range of motion. Extracorporeal shock wave therapy (ESWT) is one of the treatment options used for patients with myofascial pain syndrome through elimination of ischemia and modulation of vasoneuroactive substance (two major causes of trigger pathophysiology) and mechanical transduction as a cellular response to external stimulation. the aim of this study was to investigate efficacy of extracorporeal shock wave therapy (ESWT) on cervical myofascial pain following neck dissection surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT Group | Experimental | Device: extra-corporeal shock wave therapyreceived ESWT once a week for 4 weeks (0.25 ml/mm2, 1000 shocks) plus topical none steroidal anti-inflammatory drug (NSAID; 3 times /day for 4 weeks). |
| control group | Experimental | Drug: topical none steroidal anti-inflammatory drugreceived only topical NSAID. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Previous unilateral modified radical neck dissection.
- Patients with myofascial pain of upper trapezius for at least 3 months.
- Patients with palpable intramuscular taut band.
- Restriction in cervical ROM of lateral flexion and rotation.
- Provocation of the clinical symptoms by compression of the active trigger point
Key exclusion criteria (7 listed)
- Patient who received medication or other therapies for MPS within the previous 2 months.
- Patients with pacemaker, pregnancy
- Open wound at the treatment area.
- Cervical myelopathy or radiculopathy, cervical spine fracture or spondylolisthesis.
- Rheumatoid arthritis.
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 |
|---|---|---|
| extra-corporeal shock wave therapyAlso: shock wave therapyExtracorporeal Shock Wave Therapy (ESWT) has been introduced efficiently for more than twenty years as a treatment modality in orthopedic and musculoskeletal disorders. ESWT has mechanical and cellular impacts on tissues regeneration and pain management through cavitation bubbles, acoustic micro streaming, and hyper-vascularity that can directly affect tissue calcifications, and modulate cell activity. | Device | ESWT Group |
| topical none steroidal anti-inflammatory drugAlso: topical NSAIDparticipants received 1% topical diclofenac gel on the tender points 3 times /day for 4 weeks. | Drug | control group |
Primary outcome
Visual analogue scale
Time frame: before treatment
VAS was utilized for assessing and quantifying pain exhibited by the patients through a 0-10 cm scale. Each subject was informed to mark the line according to the pain intensity experienced at that particular time where '0' means no pain and '10' means worst conceivable pain.
Visual analogue scale
Time frame: 2 weeks of treatment
VAS was utilized for assessing and quantifying pain exhibited by the patients through a 0-10 cm scale. Each subject was informed to mark the line according to the pain intensity experienced at that particular time where '0' means no pain and '10' means worst conceivable pain.
Visual analogue scale
Time frame: after 4 weeks of treatment
VAS was utilized for assessing and quantifying pain exhibited by the patients through a 0-10 cm scale. Each subject was informed to mark the line according to the pain intensity experienced at that particular time where '0' means no pain and '10' means worst conceivable pain.
3 secondary outcomes
Cervical range of motion assessment
Time frame: before treatment
Cervical range of motion assessment
Time frame: 2 weeks of treatment
Cervical range of motion assessment
Time frame: after 4 weeks of treatment
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 17 Feb 2020.
- Results publication: PubMed 23093823Guru K, Manoor UK, Supe SS. A comprehensive review of head and neck cancer rehabilitation: physical therapy perspectives. Indian J Palliat Care. 2012 May;18(2):87-97. doi: 10.4103/0973-1075.100820.
- Results publication: PubMed 10484856Sist T, Miner M, Lema M. Characteristics of postradical neck pain syndrome: a report of 25 cases. J Pain Symptom Manage. 1999 Aug;18(2):95-102. doi: 10.1016/s0885-3924(99)00054-8.
- Results publication: PubMed 22836591Bron C, Dommerholt JD. Etiology of myofascial trigger points. Curr Pain Headache Rep. 2012 Oct;16(5):439-44. doi: 10.1007/s11916-012-0289-4.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figure)
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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.
MAGED A BASHA, Dr study director
Assistant Professor, Qassim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extra-corporeal shock wave therapy and topical none steroidal anti-inflammatory drug in people with Pain and Cervical Pain, run by Qassim University at 1 site in Egypt.
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 7 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 17 Feb 2020. 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 Egypt. 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?
Visual analogue scale (time frame: before treatment). The study lists 3 primary outcomes in all. 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 NCT04270968, which also lists 3 linked publications.
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 17 Feb 2020.