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临床试验/NCT06631222
NCT06631222已完成不适用

Effect of Cognitive Behaviour Approach on Subjects With Problematic Smartphone Use

Hatem Mostafa2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年1月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
pressure algometer

研究概览

简要总结

The goal of this clinical trial is to learn if cognitive behavioral approach works to treat tension type headache in smartphone addiction in adults. The main questions it aims to answer are:

Is there an effect of adding cognitive behavior approach to physical therapy (manual therapy, corrective exercise therapy) on pain pressure threshold, forward head posture and headache intensity in smartphone addiction patients with tension-type headache? Researchers will compare adding cognitive behavior approach to physical therapy (manual therapy, corrective exercise therapy) to see if cognitive behavior approach works to treat tension type headache in smartphone addiction than physical therapy alone.

Participants will:

All participants will receive twelve treatment sessions (twice per week) in a 6 weeks period with a rest period of 48 to 72 hour between them.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 34 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects were those diagnosed with tension type headache by neurologists based on the criteria of the International Headache Society.
  • age between 19-
  • International Headache Society diagnostic criteria of tension type headaches:
  • Frequent ETTH or CTTH diagnosed, in both cases more than three months.
  • Episodes of pain from 30 minutes to 7 days Fulfil 2 or more of the following characteristics:
  • Bilateral location of pain.
  • Non-pulsatile pain pressure.
  • Pain mild to moderate.
  • The headache does not increase with physical activity.
  • The headache may be associated with pericranial tenderness.
  • Controlled pharmacologically.
  • Myofascial TrPs were bilaterally explored in upper trapezius, splenius capitis, sternocleidomastoid, masseter, superior oblique, levator scapulae and suboccipital muscles, TrP diagnosis was conducted following the diagnostic criteria:
  • presence of a palpable taut band within a skeletal muscle.
  • presence of a hypersensitive tender spot in the taut band.
  • local twitch response elicited by snapping palpation of the taut band reproduction of the typical referred pain pattern of the TrP in response to compression.
  • TrPs were considered active if both the local and the referred pain evoked by manual palpation reproduced total or partial pattern of the headache.
  • Patients with FHP who have craniovertebral angle less than 49 degrees were included. Forward head posture is measured by calculating the angle between the horizontal line passing through C7 and a line extending from the tragus of the ear to C
  • patients with smartphone addiction who will score 31 for males and 33 for females on smartphone addiction scale - short version.

排除标准

  • rheumatoid arthritis.
  • suspected malignancy.
  • pregnancy.
  • if they had received manual therapy treatment in the 2 months before enrolment into the study.
  • Patients with infrequent episodic tension type headache, or with probable frequent and infrequent forms of tension type headache or other concomitant headache.
  • They can never have vomiting or headache episodes during the treatment.
  • Episodic tension type headache patients may experience very occasionally photophobia or phonophobia during their episodes of headache.
  • Chronic tension type headache patients may experience very occasionally photophobia, phonophobia or mild nausea during headache episodes.
  • Pain aggravated by movement of the head.
  • Metabolic or musculoskeletal problems with similar headache symptoms.
  • Previous trauma to the cervical spine.
  • Active vertigo history.
  • Poorly controlled hypertension.
  • Atherosclerosis.
  • Advanced osteoarthritis.
  • Patients undergoing pharmacological adaptation or changes in the prophylactic medication.
  • Excessive emotional stress.
  • Patients with heart devices.
  • Joint instability.
  • Neurological disorders.
  • Laxity of cervical soft tissues.
  • Radiographic abnormalities.
  • Generalized hyperlaxity or hypermobility.

研究组 & 干预措施

control group

Active Comparator

the participants will receive a conventional standard physical therapy program (sub-occipital inhibitory pressure, Spinal manipulation, deep friction massage and corrective exercises)

干预措施: Exercises for forward head posture (Other)

control group

Active Comparator

the participants will receive a conventional standard physical therapy program (sub-occipital inhibitory pressure, Spinal manipulation, deep friction massage and corrective exercises)

干预措施: sub-occipital inhibitory pressure (Other)

control group

Active Comparator

the participants will receive a conventional standard physical therapy program (sub-occipital inhibitory pressure, Spinal manipulation, deep friction massage and corrective exercises)

干预措施: deep friction massage (Other)

control group

Active Comparator

the participants will receive a conventional standard physical therapy program (sub-occipital inhibitory pressure, Spinal manipulation, deep friction massage and corrective exercises)

干预措施: Spinal manipulation (Other)

experimental group

Experimental

the participants will be treated with behavior change model in addition to a conventional standard physical therapy program for tension-type headache.

干预措施: Exercises for forward head posture (Other)

experimental group

Experimental

the participants will be treated with behavior change model in addition to a conventional standard physical therapy program for tension-type headache.

干预措施: cognitive behavioral therapy (Behavioral)

experimental group

Experimental

the participants will be treated with behavior change model in addition to a conventional standard physical therapy program for tension-type headache.

干预措施: sub-occipital inhibitory pressure (Other)

experimental group

Experimental

the participants will be treated with behavior change model in addition to a conventional standard physical therapy program for tension-type headache.

干预措施: deep friction massage (Other)

experimental group

Experimental

the participants will be treated with behavior change model in addition to a conventional standard physical therapy program for tension-type headache.

干预措施: Spinal manipulation (Other)

结局指标

主要结局

pressure algometer

时间窗: from enrollment to nthe end of treatment at 6 weeks

this device is used to describe the sensitivity of the trigger points found in cervical region

The smartphone addiction scale short version

时间窗: from enrollment to nthe end of treatment at 6 weeks

This scale is a short version that contains only 10 questions for easy smartphone addiction screening of adolescents who are considered vulnerable to addiction. This scale also provides a cut-off value to evaluate the level of addiction, to evaluate the treatment effect and to provide evidence of interventions different from those in the conventional scales. This scale has a high value as a screening tool because gender differences can be reflected in the results by providing a cut-off value for both genders, and the screening process that includes the evaluation by clinical psychologists is not merely the simple percentage calculation method but reflects the characteristics of the participants. The cut-off value for boys is 31, Meanwhile, the cut-off value, for girls is 33

次要结局

  • measurement of forward head posture(from enrollment to nthe end of treatment at 6 weeks)
  • pressure algometer(from enrollment to nthe end of treatment at 6 weeks)
  • measurement of forward head posture(from enrollment to nthe end of treatment at 6 weeks)
  • Headache impact test(from enrollment to nthe end of treatment at 6 weeks)
  • The smartphone addiction scale short version(from enrollment to nthe end of treatment at 6 weeks)

研究者

发起方
Hatem Mostafa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hatem Mostafa

assistant lecturer of physical therapy

Badr University

研究点 (2)

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